Pressures Mount as Industry Urges Excipient Regs

Emerging Markets AreTop Focus, Experts Agree

E merging markets continue to be a major focus for the evolution of thepharmaceutical industry, according to a dozen experts featured at CPhI’spre-show seminars on Monday.

The experts from across the disciplines of biopharmaceuticals, APIs, and CMOsagree that the next decade for the pharma landscape will be significantlydifferent as emerging markets, such as Asia, play an increasingly crucial role.Already a major shift is underway as the emerging markets are taking on more“Western standards,” they said.

The half-day of pre-show seminars was designed to give delegates an insightinto the minds of industry insiders and supply tips for future businessopportunities and an understanding of the trends in the pharmaceuticalenvironment. Conference attendees could choose from a selection of modulesranging from biosimilars and CROs to the rise of generics and CMO selection.

Asia has always been the original hub when it comes to emerging pharmamarkets, but it has also had its share of pitfalls, particularly in terms of safety andquality. Yet the attraction of low costs has kept the region on many a savvypharma’s radar and outsourcing and start-ups are likely to continue.

Tuesday night’s Exhibitor Party feted the winners of the 2009 CPhI Innovation Awards:

Gold went to Puleva Biotech Exxentia, accepted by Arjan Geerlings, center; Silver was won by Cambrex, accepted by Jayne Muir, left; and Bronze went toNovozymes Biopharma, and accepted by Dave Mead, right. Thursday’s Show

Daily will profile the innovations of all six finalists.

Pressures Mountas Industry UrgesExcipient Regs

E xcipients need to be regulated if the developmentof drugs is to move forward in the future, says onesenior pharma executive.

Speaking at a breakfast meeting on Tuesday, ArnulfHeubner, senior director at Merck Darmstadt, explainedthere were increasing pressures for good quality, safetyand efficacy of excipients, and the need for strongerregulation and certification.

Currently, excipients make up about 90% of the bulk ofdrugs, with APIs making up just 10%. Yet, despite thismajority, excipients are not regulated other than throughthe pharmacopoeia that only measures 10-20 criteria, hesaid, adding that self-regulation of excipients throughaudits is patchy.

In 2007, the European Fine Chemicals Group (EFCG), ofwhich Heubner is a member and chairman of itsPharmaceutical Business Committee, proposed thecreation of certifiable standards for excipients. It listed a

three-tier classification system—common, specific, andnovel excipients.

Joint activity by IPEC America, IPEC Europe, thePharmaceutical Quality Group (PQG), the EFCG, and theEuropean Association of Chemical Distributors (FECC) haspropelled plans in an excipient certification scheme, whichwould contain supplier qualifications, third party auditsand accreditation, classification of excipients andcertification of suppliers, including GMP. Heubner alsobelieved that European directives should extend to coverexcipients.

continued on page 4continued on page 3

Innovation Award winners:

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CPh I S H O W D A I L Y | WEDNESDAY | 1 4 O c t o b e r 2 0 0 9 | F e r i a d e M a d r i d 3

Table of Contents

TODAYICSE Speakers’ Corner . . . . . . . . . . . . . . . . . . . . . 4

CPhI Speakers’ Corner . . . . . . . . . . . . . . . . . . . . . 5

Calendar of Events . . . . . . . . . . . . . . . . . . . . . . . 46

Product News . . . . . . . . . . . . . . . . . . . . . . . . . . 6–46

Advertisers’ Index . . . . . . . . . . . . . . . . . . . . . . . . 47

“This is a step in the rightdirection,” Heubner said.“This is the only way tocontinue to make drugssafer and better.”

The relative regulation-free excipient market hasenabled many suppliers tocut corners to save costs.For example, in the past,diethylene glycol, achemical in antifreeze, wasadded to a number of drugsto replace the moreexpensive thickening agentglycerine. This has led tocases of poisonings andeven fatalities.

“This scheme will prevent this sort of thing happening again in the future. Notonly will it certify the production process, but it will also certify the distributionprocess as well. This scheme gives a holistic view of the whole supply chain.”

The EFCG previously proposed a certification and regulation scheme for theproduction of APIs. While API manufacturers are inspected by authorities and aregenerally self-regulated through audits, worldwide inspections are not alwaysconsidered to be at a satisfactory level, particularly outside of Europe and the U.S.

Off-patent APIs are of particular concern. Guy Villax, chief executive of Hovione,noted that as big pharmamoves to generics as theyface patents expiring, theindustry is beginning to re-alize a shortfall of data.“They are waking up thatthey don’t have this data ongeneric suppliers of APIs,”he said.

The trend toward certifi-cation standards follows thelaunch of RX-360, an interna-tional industry supply chainsecurity consortium, which islooking to adopt existingstandards. Members will beable to share informationfrom GMP compliance auditreports, and request new au-dits. The costs will be sharedwith other RX-360 members, meaning pharma will be able to gather data-points on sup-pliers—not only of APIs, but also excipients and intermediates.

Although progress continues toward excipient certification regulations, it will beyears before a full system is in place. However, by the second quarter of next year, aframework for the excipient certification scheme may be ready for review, whilenegotiations will continue for several more years. •

Joan Moynihan, the long-time and highly-regarded editor of theInternational Trade Show Press dailies, including the CPhI ShowDaily, died last year as a result of medical complications following aheart attack in March.

From Industry Urges 1

Arnulf Heubner, senior director at Merck Darmstadt

Guy Villax, chief executive of Hovione

Correction: The photograph of SAFC Pharma’s president in Tuesday’s Show Dailywas inadvertently mislabeled. Gilles Cottier is SAFC’s president.

One such company is AstraZeneca, which, in 2007, decided to outsource all APIsover the next five to 10 years. Thecompany looked at theopportunities in Asia and decidedthere was a strong push to move tooutsourcing, said CharlottaElgström, global category leader APIsourcing, AstraZeneca at the APISourcing module. While theexperience has not lived up toexpectations—not all suppliers are

cheaper than those in Europe and there is occasionally a disadvantage with culturaldifferences—she said that the suppliers are typically responsive.

Interestingly, the region is now also starting to see itself as catering not just toforeigners like AstraZeneca, but adding to the domestic growth and potential in itsown countries, said DaveJohnson, head of globalsourcing Asia, at Perrigo.Indeed, “Asian API suppliers arehere to stay,” he told theaudience.

The same can be said aboutCMOs in general. Currently,India-based Piramal Health andJubilant Organosys are placedin the top 10 CMOs, said KeithSchlagbauer, director of healthcare consulting Europe, Frost & Sullivan, in the CMOselection and partnerships module. He believes other such CMOs would work theirway up the ladder. “This picture is clearly going to change. Look at the top 20 pharmamanufacturers. We are starting to see shifts occurring in this top 20 as well.”

Western-based CMOs are also increasingly locating facility sites in emergingmarkets such as Catalent in South America and Lonza in China.

That goes hand-in-hand with GMP in emerging markets, which was compared to atoothbrush by Anulf Heubner, senior director,Pharma Raw Materials, during theBiopharmaceutical and Biosimilar module.Even if a toothbrush has been checked forgerms, you still wouldn’t want to use it if ithad been found on a toilet floor, heobserved. “This is the difference from fiveyears to today. We are trying to cover thewhole process chain from raw materials webuy to the material when it is released byour customers.” l

4 C P h I S H O W D A I L Y | WEDNESDAY | 1 4 O c t o b e r 2 0 0 9 | F e r i a d e M a d r i d

From Emerging Markets 1

Speakers’ CornerPresentations

Hall 8, Stand A42—Wednesday10.00–10.25 Capsugel

Topic: DBcaps®, Simplify and Speed up Double-blind Clinical TrialsSpeaker: Dr. S. Stegemann, Director Pharmaceutical BusinessDevelopment EMEA

10.30–10.55 Valois Pharma Topic: Development of a Novel Dry Powder Inhaler Device:Prohaler Speaker: Guillaume Brouet

11.00–11.25 Syntagon Topic: Controlling Potential Genotoxic Impurities for Phase I Clinical Trials Speaker: Anders Högdin

11.30–11.55 Ecron Accunova Topic: The 505(b) (2) Alternative—An NDA that Saves Time andMoneySpeaker: DA Prasanna—Founder & Vice Chariman, ECRON ACUNOVA

12.00–12.25 Nicomac Srl Topic: High Potency Product Containment—Isolation Technology Speaker: Tomaso Nigris, Managing Director

12.30–12.55 Richter-Helm Biotec Topic: Customised Solutions in Biopharmaceutical Manufacturing;Integration into Drug Development Programs Speaker: Federico Pollano

13.00–13.25 Reig Joffre Group Topic: Main Manufacturing Challenges in Lyophilisation Processes Speaker: Mercè Pujol

13.30–13.55 SGD Topic: Pharmaceutical Glass Vials for Freeze-dried Drugs Speaker: Vincent Langlade—Marketing Director Pharmaceuticals

14.00–14.25 SGS Life Science Services Topic: Direct Your Leachables/Extractables Assessment Speaker: Dr. Andreas Nixdorf

14.30–14.55 Vetter Pharma International GmbH Topic: Key Factors to reduce time to market—Development ofAseptic Pre-filled Application Systems Speaker: Hermann Piana

15.00–15.25 Fresenius Kabi Product Partnering Topic: Emulsions—Established and Promising Drug Carriers forParenteral Administration Speaker: Anton Gerdenitsch

15.30–15.55 Catalent Pharma Solutions Topic: Poorly Soluble Drugs: Softgel Lipid Based Formulations toMaximise Oral Absorption Speaker: Bruno Cuime—Sales and Business Development Manager,Pharmaceutical Softgel, Europe

16.00 - 16.25 Almac Group Ltd Topic: Almac RAPIDD™—Would you like to save 12 months in earlystage clinical development? Speaker: Denis Geffroy

Track & Trace Pavilion Debuts at ICSEGlobal concerns with counterfeiting and product contamination risks are drivingever-tighter regulations to secure pharma supply chain safety and productauthenticity and traceability.

The Track and Trace Pavilion is the first of its kind to showcase solutions at a majorEuropean pharma services event. Key exhibitors are presenting a wide range oftechnologies and services.

Wireless tracking and tracing solutions have moved a long way beyond theoriginal “RFID.” Complete solution packages now encompass identification (RFID, EPC,bar codes), location (GPS WiFi), condition (temperature/humidity/chemical sensorsand sensor networks), and business intelligence software systems utilizing a mix ofthese technologies.

Track and Trace is a UBM brand embracing wireless tracking and tracingtechnology events, conferences, and online information. Pharma, food ingredients,chemicals, and personal care are among the lead sectors to benefit from thetechnology. l

Kate Kuhrt

Deepak Sapra


Wednesday—14 October10.00–10.25 Phosphonics

Topic: Novel Functionalised Silicas: Purification and Catalysis

Applications for Pharmaceuticals

10.30–10.55 SPI Pharma

Topic: Pharmaburst(R) 500: Evolutionary ODT Performance

11.00–11.25 Chemetall

Topic: Cesium Salts in Organic Synthesis—The Key to Optimized,

Sustainable and Cost Efficient Processes

11.30–11.55 Asociacion Forum Auditorias (AFA)

Topic: Qualification of Suppliers: A Key Process of The Pharmaceutical

Quality System (ICHQ10)

12.00–12.25 PV-Solutions

Topic: Pharmacovigilance for Generic MAHs in the EEA

12.30–12.55 Thomson Reuters

Topic: “Keeping Track of Changes in the Constantly Evolving

Regulatory Environment”

13.00–13.25 DSM Pharmaceutical Products

Topic: Micro Reactor Technology: Cost-Effective, Environmentally

Friendly Large-Scale API Production

13.30–13.55 Covex, SA

Topic: Naturally Occuring APIs—Pharma or Nutrition?—A Booming

Business with the Best of Both

14.00–14.25 Solvias

Topic: “Hydrate or Anhydrate?” More than a Philosophic Question

During Drug Development

14.30–14.55 Novozymes

Topic: Safe Products and Technologies for the Biopharmaceutical

Industry—Optimizing your Manufacturing Process, Drug Formulation

and Drug Delivery

15.00–15.25 LGC Standards

Topic: The new FDA guidance “ANDAs: Impurities in drug substances”

its implications for the industry and other news

15.30–15.55 Fuji Chemical Industry Co.,Ltd

Topic: F-MELT® New Strategy and Method to Develop ODTs

16.00–16.25 LisaPharma

Topic: Platforms in Drug Delivery for Innovative and Versatile Drug

Products: The Lisapharma S.P.A and University Deal

16.30–16.55 Saltigo

Topic: Our Expertise, your API Solution

Audits have become morechallenging in the past five years,which has improved the process.

This also reflects a new trend, aslaid out by Deepak Sapra andDurgesh Sharma of Dr. Reddy’s inthe API Demand and the Rise ofGenerics module. Sapra andSharma, respectively head of APImarketing for Latin America andhead of API marketing North Asia,suggested that a regulatory shift isunderway—due to a change in emerging market mindset, where regulations are nolonger a formality but will be a pre-requisite. The better a company can adapt, the

more successful it will be, they agreed.The trend was also suggested by

Christopher Klein, head of globallicensing, Sandoz Biopharmaceuticals,who believes that most emergingmarkets will catch up to Westernstandards and be highly regulatedwithin the next 10 years.

But it is not just Asia or LatinAmerica getting a chunk of the action.Eastern Europe is also seeing an

increase, particularly in clinical trials, said Franz Janik, chief executive at Innophar, atthe CRO and Clinical Trials module. Among many advantages, including centralizedhealthcare systems and rapid recruitment times, he conceded there are stillchallenges such as lack of equipment or adequate medical comparators.

As the pharma environment changes, it is possible more companies will share therisk of developing drugs. Speaking at the In-licensing & Out-licensing module, KevinBottomley, senior principal, PharmaVentures, said “licensing is the ideal way to getgenuine value fromproprietary assets,especially if you don’thave the resources totake the product tomarket—and at this pointin time very fewcompanies have thatprivilege.” Companiesmay try to reduce theirexposure to risk in allstages of development inthe future, he added. •

ICSE and P-MEC event director HafCennydd commented: “Thecompliance and safety imperativesmean that pharma ingredient andproduct tracking and authenticityhave become business-critical issues.This calls for end-to-end ‘track andtrace’ solutions and we’re delightedwith the platform opportunity that

ICSE is giving to both potential customers and providers.”Track and Trace’s predecessor—the RFID World conference and exhibition—was

first launched in 2002.Track and Trace was featured at mid-September’s Health and Beauty America

event in New York and will be at the Food Ingredients Europe exhibition (Nov. 17–19 inFrankfurt), ahead of staging the innovative online Track & Trace Virtual Tradeshow onDec. 2–3.

For more information on Track and Trace in Madrid: www.icsexpo.com •

Identification technologies andsolutions crucial to safe and securepharma supply chains and productpackaging are the focus of standsand exhibitors in ICSE’s Track andTrace Pavilion—organized andhosted by UBM.

Dave Johnson

Diane Smets, Tom Niemeyer, and Franz Janik

Gabriela Von Der Hoeh


Merck Chemicals’Presence In Dual Areasand New ProductsMerck Chemicals has two booths this week at CPhIWorldwide—but with a single aim: “Showing clientsthe paths we can take together.”

Merck is presenting its biopharma portfolio on adedicated booth for the first time—Stand Bio16,Hall 8. Topics range from upstream, through down-stream to formulation, with launches for the new“smart” resins Eshmuno S and GMP Process Solu-tions.

In another area (Stand E06, Hall 3), MerckPharma’s focus products are Parteck ODT,Sucralose Emprove, and non GMP forpharmasynthesis.

Highlights of the respective stands are:• In Merck4Pharma, the company presents

Parteck ODT and continues innovating in directcompression excipients, a new drug applicationfor direct dispersion in the mouth. Also MerckChemicals presents the new sweetener that willrevolutionize the new releases of thepharmaceutical sector, Sucralose EMPROVE.

• Driven by the need to provide transparencyalong the whole pharma production chain, thecompany is introducing this new line “forpharma synthesis, non-GMP.”

• In Merck4Biopharma, Eshmuno S is the new“smart” resin for purification of monoclonalantibodies, a new era in high performancepurification of biotechnology.

Visit Merck at Stand 3E06, Hall 3. •

Indian CRO Can Gear Up QuicklyEcron Acunova is a full-service CRO with a two-decade track record of providing end-to-end services for Phase I-IV clinical research, including central lab, BA/BE, PK/PD,and early development services for pharma, biotech, nutritional, device, and thediagnostics industry. With an established presence in Asia, Europe, and the U.S., thecompany is experienced in conducting clinical trials for bio-similars, medical devices,radio pharmaceuticals, and diagnostic agents.

In India, it has preferred access to 19 teaching hospitals of Manipal University with1,500 physicians who treat 1.5 million patients per year. The company’s databasecontains more than 4,500, including female volunteers and special populations forstudies focused on post-menopausal women, geriatric volunteers, oncology,psychiatry, dermatology, and diabetes. This excellent patient access leads to speedyrecruitment, as well as beneficial time and budget effects for the company’s clients.

Equipped with advanced infrastructure, the company conducts PK/PD studies inits three clinical pharmacology units (CPU) with 150 beds situated in universityhospitals. The CPUs are designed for first-in-man, dose escalation, drug interaction,mixed gender, and larger pivotal studies. All studies of these CPUs are approved by aUniversity Ethics Committee, which is constituted as per the Indian council of MedicalResearch (ICMR), complies with ICH GCP, and is registered with Office for HumanResearch Protection (OHRP) —U.S. Dept. of Health and Human services.

It has well-integrated services like a CAP accredited and NABL certified clinicaltesting laboratory, a GLP compliant bioanalytical lab with LC-MS/MS instrumentation,and a ISO 27001: 2005 certified biometrics facility that is supported by a clinicalinformation team. The company has conducted studies for US FDA, WHO, EMEA, UKMHRA, Health Canada, and DCGI submissions. Ecron Acunova has been inspected byUS FDA and WHO, and the studies conducted for the drug molecules were approved.

Visit Ecron Acunova at Stand 8CT25. •

Green Solvent Has Bright Future2-methyltetrahydrofuran, 2-MeTHF, remains one of the fastest growing solventmarkets based on its superior technical, commercial, and environmental advatages.

Pennakem (prevously Penn Specialty Chemicals) has been a niche market playerin the furan chemistry for more than 50 years and has recently marketed 2-MeTHF asa viable alternative to the classic aprotic solvent tetrahydrofuran. The THF solventmarket is estimated at around US $200 million per year globally.

Bogdan Comanita, director of technical marketing and sales for Europe, sees atwo-fold value proposition for 2-MeTHF versus THF: it is simultaneously a cost cuttingsolution and a greener alternative.

The lower cost stems from higher reaction yields, better extractive/crystalizationproperties, and shorter cycle time. For example, in the generation of the benzylicGrignards, MeTHF gives improved yields by at least 15 % compared to THF. Also, it wasfound that regio and stereoselectivities are improved in 2-MeTHF compared to othersolvents.

2-MeTHF is also a greener solvent since the specific consumption is reduced in sev-eral ways. Since 2-MeTHF is not water miscible, the addition of a second hydrophobicsolvent for the aqueous work up is not needed to achieve phase separation.

At the same time, 2-MeTHF distills at atmospheric pressure as a rich waterazeotrope, just like toluene. This renders recycling and re-usage of 2-MeTHF in one-pot reactions possible. The reduced water miscibility, the higher boiling point, andthe ease of recycling/re-use reduces the environmental footprint of the solvent.Additionally, 2-MeTHF is obtained from renewable resources unlike THF, which iscurrently an oil derivative.

MeTHF, a green solvent combining THF chemical properties with toluene’s physicalproperties, can cut costs and minimize ecologic footprint.

Visit Pennakem at Stand 5A30. •


Catalysis: Evonik, Solvias Renew License AgreementThe Catalysts Business Line of Evonik Industries and the Swiss-based companySolvias have renewed their license agreement for vanadium-doped precious metalpowder catalysts for the hydrogenation of nitro compounds.

Evonik will continue to market these catalysts, which were developed by Solvias,on an exclusive basis, but the underlying business model has been greatly simplified.“Anyone purchasing these catalysts from Evonik now automatically acquires the rightto utilize the technology,” explains Jürgen Krauter, head of marketing at Evonik’sCatalysts Business Line. “Additional license agreements and fees will no longer benecessary. What remains is a high-performing technology that converts evencomplicated nitro compounds into amines reliably and with high yields.”

The vanadium-doped precious metal powder catalysts can be used for selectivehydrogenation of nitro aromatics. Their advantage compared with other catalysts isthat they do not target the halogen substituents in the target molecule. That makeshandling nitro compounds safer and generates fewer by-products.

For highly complex nitro aromatics, Evonik offers a second form of this catalystwhich is additionally modified with hypophosphoric acid. This is used where othercatalysts reach their limits: When the target molecule contains reactive componentssuch as double and triple bonds, carbonyl groups or highly reactive oxime groups aswell as halogens. Here, too, the catalyst ensures selective hydrogenation of the nitrogroup only and thus obviates the need for time-consuming use of protective groups

Solvias uses technology for customized process optimizationSolvias will continue to use this technology for customized process development andoptimization. “This technology complements Solvias’ broadly based expertise in het-erogeneous catalysis, which ranges from the development of heterogeneous cataly-sis technologies and high-pressure hydrogenation through the implementation ofmanufacturing processes to process development and scale-up in our GMP laborato-ries,” commented Stephan Haitz, head of marketing and sales at Solvias. This Swisscompany retains access to the entire platform of technologies for hydrogenation ofnitro groups with vanadium-based catalysts. Alongside the ready-to-use vanadium-doped catalysts marketed by Evonik, this includes in-situ variants comprising plat-inum catalysts to which a vanadium salt is added during the reaction. •

New Zones for 2010 WorldwideNext year’s CPhI Worldwide in Paris will introduce dedicated exhibitor zonesfor easier, faster navigation and transit and increased focus on key productsectors. The move will help visitors to make best use of business time at theevent.

A new layout over the two CPhI-dedicated halls will introduce six zones:APIs, Custom Manufacturing, Intermediates, Fine Chemicals, Excipients, andGeneral (multiple sector involvement/trading/distribution).

Zones will be prominently signed via individual color coding and distinctivesymbols. UMB organizers say the move both directly responds to exhibitor andvisitor feedback and flags continuing event growth in the major businesscategories.

“Zoning will help our visitors to plan and make the very best use of time atthe event—with easier, faster navigation between and within areas, more timedoing business and less time in transit and traffic between stands,” said CPhIevent director Annemieke Timmers.

Zoning also benefits exhibitors: “Dedicated zones make the event morelogical, and increase focus for exhibitors. They draw visitors more quickly andeasily into their areas of interest – and provide added opportunities forexhibitors and visitors to network and make new contacts,” Timmers added.“Bringing businesses from a given sector together will also help to raise sectorprofile and showcase its distinct qualities.”

Set for Oct. 5–7 next year, CPhI Worldwide 2010 will be timed a week earlierthan the 2009 exhibitions. Villepinte Paris Nord, which last hosted CPhIWorldwide and its co-located events in 2006, will be the site again in 2010. •

Group Launches One-StopCapability Package

With a two-year investment, restructuring and expansion program, CustomHealthcare Group is launching a new fully integrated suite of customer supportservices, including research and development, super-food ingredients sourcing,contract manufacturing and packaging, and testing and quality control, as well asstorage and distribution direct to retail.

Its laboratory, manufacturing, and packaging facilities for the UK, Europe, China,and Far East are equipped to handle high volume, low volume, and niche and samplevolumes.

Dedicated market divisions for the healthcare, medical, and pharmaceuticalscustomers are project managed by experienced market professionals.

A new state-of-the-art facility in Jinan, China offers exciting opportunities forcustomers to exploit cost-effective retail routes into Europe, China, and the Far East.

At CPHI and ICSE this week, Custom Healthcare Group brings a host of individualpackaging, manufacturing, product development, and technical services, as well aspackaging ideas, quality ingredients resource, and a fully integrated, one-stopresource for customers in fast moving retail environments.Visit Custom Healthcare at Stand 8A13. •

Group Delivers Range of Services forChemical Development, ProductionHalogen expertise. Building Block chemicals on commercial scale. Extensive couplingtechnologies. Custom synthesis, including GMP from small scale to MT. These are a fewof the elements that the Tosoh Fine Chemical Group of companies brings tochemical development and commercial production programs.

The Tosoh Fine Chemical Group companies consist of: Tosoh Finechem, Tosoh F-Tech, Tosoh Organic Chemical, and Manac. Alone, each company is a recognizedexpert in chemical products and unique technologies. Together, the group offers awide array of unique products and services all under one umbrella.

The Group’s technology expertise in selective halogenation (Bromine, Fluorine,Chlorine and Iodine) enables the production of unique stand-alone products ortailored materials that become the starting point for further reactions.

Further expertise in coupling reactions including the production and use ofGrignard reagents and boronic acids, along with a variety of unique catalyticcoupling agents enable the production of a range of useful functionalized products.The Tosoh Group continues to invest a substantial amount of resources into basic andapplied R&D to continuously add to and improve product and service offerings.

Along with technology, the group brings a large array of equipment resources tohelp to meet target products. The Japan-based facilities offer 158 reactors up to10,000L. Temperature capabilities to -100°C and many GMP covers the flexibility toaddress any project.

Visit Tosoh Fine Chemical Group at Stand10G20. •


ACG Pharmapack Launches UltraSafe

Introduced by ACG Pharmapack, UltraSafe is ahigh barrier blister film coated with special PVdcthat gives high barrier protection againstmoisture and gas. UltraSafe provides the user witha choice of using a transparent blister film fortheir products that require protection from

moisture unattained by the conventional blister film offering medium barrier.Offering greater barrier than conventional PVdC barrier films, both Dupac and Tripacfilms are possible with Ultrasafe.

ACG Pharmapack is a member of ACG Worldwide, one of the largest and mostreputed groups in the manufacturing and marketing of empty hard gelatin capsules,packaging films, capsule filling equipment, blister packing, and cartoning machines.

Visit ACG Pharmapack at Stand 8G35. •

Advanced Cyclone Systems AddressesEfficient Powder Recovery Problems

Pharmaceutical companies that produce active pharmaceutical substances throughspray and fluid bed drying are the prime target for Hurricane and ReCycloneSystems—solutions from Advanced Cyclone Systems that address problems ofefficient powder recovery.

Efficient recovery of Active Pharmaceutical Ingredients (APIs) after spray and fluidbed drying continues to challenge pharmaceutical and biopharmaceuticaloperations. For the recovery of these sensible products, cyclone collectors arefrequently vital pieces of equipment to capture the powder directly and avoidcontamination of filter bags, as well as product degradation with temperature.However, product losses due to cyclones’ low efficiency can be costly.

Hurricane cyclones demonstrate impressive efficiencies in capturing inhalablepowders with a Median Volume Diameter (MVD) of less than 3-5µm. These cycloneswere obtained after years of work in partnership with the Faculty of Engineering ofPorto, Portugal.

Hurricane geometries maximize powder collection for each different application,while minimizing re-entrainment and keeping pressure drop at reasonable levels. Asingle Hurricane is more efficient than other cyclones available in the marketplacefor the same pressure drop.

Hurricanes have been acquired in 2009 by one of the leading companies inparticle design through spray drying.

A ReCyclone is composed of a Hurricane and a particle separator (mechanical orelectrostatic re-circulator), placed downstream of the cyclone.

The main purpose of the recirculation is to reintroduce the fine non-capturedparticles into the cyclone after they have been driven to the outer walls of the re-circulator by centrifugal or electrical forces. While this tangential gas stream isenriched in particles, the axial gas stream exhaust to the stack is practically invisible.

Efficiency increases due to recirculation and agglomeration of very smallparticles with larger ones coming directly from the process. Emissions from anelectrostatic ReCyclone can be as low as those from a typical bag filter.

Visit Advanced Cyclone Systems at Stand 8G31.•

1 0 C P h I S H O W D A I L Y | WEDNESDAY | 1 4 O c t o b e r 2 0 0 9 | F e r i a d e M a d r i d

Radiolabeled Compounds Can HelpPredict Earlier Success Pharmaceutical developers have put enormous efforts into streamlining the processof drug development across the entire spectrum, while trying to better predict adrug’s success. By using radiolabeled compounds in such key parts of the drugdevelopment continuum as preclinical and clinical absorption, metabolism, andelimination (AME) studies, companies can improve the odds of compressingtimelines, potentially reduce overall costs, and maintain regulatory-required qualityand standards.

Experimental trials known as bridge studies use radiolabeled compounds inhumans at a low dose and compare the results from similar animal studies. If thepharmacokinetic results from both studies are similar in AME, it is representative thatthe drug’s other behaviors in humans will also be similar to those in animals. Thisunderstanding has already led the Food and Drug Administration to call for earlierAME studies on humans to strengthen IND submissions.

Aptuit is able to coordinate with its customers and begin working together earlyin the preclinical stage to provide expert services and guidance throughout the AMEprocess. While these studies have previously seen lag times between theradiolabeling process and gathering drug metabolism data, Aptuit’s in-housecapability to conduct and plan these processes in parallel can successfully reducetimelines. The company’s high standard of quality also ensures that properprocedures are implemented to comply with regulatory standards and maintain GMPcompliance.

The experience and expertise necessary to synthesize and produce radiolabeledcompounds to be used for preclinical and clinical AME studies can be overwhelmingin scope for even larger drug developers. In the end, an efficient and focusedcompound selection process is necessary and cost-effective. Aptuit works with thecustomer to provide integrated services to streamline radiolabeled bridge studiesfor a decisive prediction of clinical success.

Visit Aptuit at Stand 3F56 in Hall 3. •

U.S. Company Offers Custom Approach toManufacturingFounded in 1968, Reliable Biopharmaceutical has evolved from a chemicalmanufacturing plant to a leader in purified processing chemicals and APImanufacturing, holding 13 active DMFs with several in development. ReliableBiopharmaceutical is an integrated injectable API development and cGMPmanufacturing partner that provides security and speed to market approval throughfull project management, including complex science, regulatory and analyticalexpertise, and open communication.

Reliable has success within high potency (HP) products, oncology, CNS, andcardiovascular product lines and a customer base within FDA- and EMEA-regulatedindustries such as parenteral pharmaceutical, generic pharmaceutical,biotechnology, and cosmetic industries. Initial successes with Small BusinessInnovation Research grants from the National Institutes of Health, including theprestigious Tibbetts Award in 1997, laid the technical foundation that defines ReliableBiopharmaceutical.

It also manufactures intermediate products and highly purified processing chemicals,among which are Urea Ultra Pure, Tris HCl, Tris Ultra Pure, Sodium Dodecyl Sulfate- HighPurity, Purified Phenol Liquefied, Carboxypeptidase B, and Lactobionic Acid. ReliableBiopharmaceutical provides a secure supply chain with cGMP controls for high purityprocessing ingredients, including excipients, enzymes, buffers, and surfactants that arecustomized to each customer’s project, thus controlling the lot variability and optimizingeach customer’s process. This custom approach provides cost savings and productsecurity by eliminating bulk ingredients with standard specifications.

The fully audited and cGMP facility is located in Saint Louis, MO, and has had manyyears of strong growth with customers worldwide due to innovation and purification.To support this direction, Reliable recently commissioned an additional highcontainment suite and a barrier isolator chamber for the manufacture andpackaging of potent compounds.

Visit Reliable Biopharmaceutical at Stand USP036, Hall 4. •

CPh I S H O W D A I L Y | WEDNESDAY | 1 4 O c t o b e r 2 0 0 9 | F e r i a d e M a d r i d 1 1

SMB Technology To Enable U.S.Innovator’s Late-Stage ClinicalDevelopment Program Arch Pharmalabs (Mumbai, India) and Orochem Technologies (Lombard, IL, U.S.) haveformed a strategic partnership to manufacture a U.S. innovator’s API in late-stageclinical development using Simulated Moving Bed (SMB) technology in a key step ofthe synthetic route. The collaboration represents the first time that plant-scale SMBhas been used in India. As primary supplier, Arch will also produce post-approval,multi-MT API requirements for this innovator.

Using its flexible SMB capabilities, Arch Pharmalabs can cost-effectively enableAPI manufacture throughout the product life cycle: • Preclinical: Lab scale, 50g-1 kg.• Phase I-III: Pilot scale, 2-500 kg.• Launch: 500 kg to multi-MT.

With annual revenues of $195 million (US), 2,400 employees, and 11 manufacturingfacilities (including cGMP, US FDA- and EDQM-approved sites) backed by two state-of-the-art Process Technology centres, Arch Pharmalabs is a top-tier, India-based pure-play provider of API development and manufacturing services to the globalpharmaceutical industry. In addition to SMB, Arch Pharmalabs’ capabilities includebio-catalysis, high-potency manufacturing, cryogenics, phosgenation,organometallics, diketene, and other specialized chemistry. The company offersprocess R&D, custom synthesis and manufacture of intermediates and APIs for pre-clinical, clinical and post-approval requirements that are supported bycomprehensive analytical and regulatory services.

Arch Pharmalabs also offers a wide range of merchant APIs backed by DMFs andother suitable documentation. Orochem Technologies develops and manufacturesSMB equipment and a variety of stationary chiral and achiral chromatographyphases for Bioanalytical, Solid Phase Extraction, Flash, and Preparative applications.

Visit Arch Pharmalabs at Stand 5E38. •

Manufacturer Earns SafeBridge “Potent Compound Safety Certification”

Novasep, a leading producer of activepharmaceutical ingredients (APIs) andpurification technologies for the lifescience industries, has recently receivedthe “Potent Compound SafetyCertification” from SafeBridgeConsultants for its Le Mans (France) site.

The SafeBridge Potent CompoundSafety Certification program verifies Novasep’s performance in the management,evaluation, containment, control, and communication elements of HPAI productionoperations. SafeBridge Consultants conducted a 60-element review of programs,procedures, containment, and control of APIs at Novasep’s Le Mans site.

Based on the quantitative results, SafeBridge certified that Novasep meetscurrent industry standards for the safe handling of potent APIs in the identifiedareas. The certification applies to the R&D laboratories, the kilolabs, a manufacturingscale synthesis area, and the company’s associated quality control laboratories.

The SafeBridge certification demonstrates the know-how, expertise, andcontinued commitment of Novasep in the safe handling of highly potent compounds.At the Le Mans site, Novasep offers a unique combination of total synthesis,extraction, semi-synthesis, and chromatographic purification using the company’spreparative HPLC technologies for laboratory to commercial scale manufacturing ofa broad range of HPAIs, including cytotoxics.

In addition to the potent compound safety certification at Le Mans, Novasep’sLeverkusen site in Germany passed FDA inspection in May. As was the case with theprevious inspection in 2004, no inspectional observation (form FDA 483) was issued,confirming the continued commitment of Novasep’s Leverkusen facility to complywith current GMP and ICHQ7A guidelines for the manufacture of advancedintermediates and APIs. Visit Novasep at Stand 3A38. •

Generics Manufacturer Has Worldwide PresenceGlenmark Generics, a subsidiary of Glenmark Pharmaceuticals, aims to be a globalintegrated generic and API leader. With a presence in North America, EU, andArgentina, GGL markets more than 45 APIs to more than 80 countries. It has morethan 30 USDMFs filed, along with several Canadian DMFs, EDMFs and CEPs/CoSs. APImanufacturing facility is certified by FDA(US) and MHRA(UK).

The formulation plant at Goa, India is certified by FDA(US), TPD(Canada),MHRA(UK), and many other overseas regulatory authorities. Glenmark Generics USAhas more than 35 generic products in the U.S. market which includes a mix of oralsolids/oral liquids/semisolids focused on niche categories of controlled substances,modified release, and dermatology.

GGL has more than 40 pending ANDAs in various stages of approval with the U.S.FDA. For the European generics market, Glenmark Generics Europe launchedPerindopril tablets in the UK in this financial year, and subsequently launched theproduct in Netherlands.

Glenmark Pharmaceuticals (GPL) is a leader in India in the discovery of new mole-cules both NCEs (new chemical entity) and NBEs (new biological entity). Presently,Glenmark has a pipeline of 13 molecules in various stages of preclinical and clinicaldevelopment. Of these, seven molecules are in clinical trials, with potential peaksales opportunity for each molecule being in the range of USD 1 billion to 3 billion.GPL has out licensed the molecules in the last five years collecting USD 110 mn as up-front payment and significant milestone payments, if the molecule progresses fur-ther in clinical trials. Glenmark was awarded by SCRIP as the “best pharma companyin the world—SME” and “best company across emerging markets” for 2008.

For more information, visit Glenmark Generics at Stand 6C48 or www.glenmark-generics.com •


New Facility To AugmentManufacturing Strengths

Carbogen Amcis is inthe final stages ofcommissioning its newHiPo facility in Bavla,India. The new, purpose-built facility extendsthe scale ofmanufacture of HighlyPotent APIs from 600 Lin the existing Swissfacilities to 1,600 L inthe first phase of thenew plant. It offerscustomers the ability toremain with onedevelopment partnerbut benefit fromeconomies of scale inmanufacture to supportproduct lifecyclemanagement. At bothlocations CarbogenAmcis can produce HiPoAPIs with an OperatorExposure Limit (OEL) of<1µg/m3.

Its in-house toxicology group assesses both intermediates and final product toallocate the most appropriate containment throughout the synthesis. Smart supplychains can then be established to produce the most cost effective long-termsynthesis. This strategy takes advantage of different scales of production, non-GMPand cGMP assets, as well as containment infrastructure to support an OEL of <1µg/m3

at both Carbogen Amcis and its parent company, Dishman Pharmaceuticals andChemicals Ltd.

Visit Carbogen Amcis at Stand 4F82, Hall 4. •

Single-Dose Ampoule Available for Lyophilizates

A new plastic, single-dose ampoule from B. Braun, designed to increase safety and con-venience during patient care, is now available for the company’s contract manufacturingcustomers as a state-of-the-art container for suspending lyophilizates.

Mini-Plasco connect has a leading-edge design, featuring a Luer connector and atwist-off cap with integrated finger stopper. These features set new standards in:

• Preventing microbial contamination• Eliminating particle contamination• Protecting against sharps injuries• Promoting intuitive handling• Eliminating DEHP, PVC, and latex-related risks

Mini-Plasco connect is made of polyethylene, which is unbreakable and allows worry-freestorage and handling. The unique twist-off cap with integrated finger stopper enables a se-cure grip and prevents contamination of the ampoule opening. Furthermore, Mini-Plascoconnect collapses during withdrawal, allowing vent-free aspiration in one single step.

Its functionality represents an essential added value and consequently a strongcompetitive advantage. Customers can take advantage of this unique container bychoosing B. Braun OEM’s contract manufacturing services in the Mini-Plasco connect(container as primary packaging for their solution) or by choosing the container assecondary packaging to complement to their drug (e.g., Mini-Plasco connect withstandard solution as diluents for customer’s lyophilized drug).

Based on the expertise of B. Braun, the OEM division supplies system-built out-sourcing solutions to the pharmaceutical and medical devices industry. The division’sproduct portfolio includes pharmaceutical solutions, medical devices, and productsfor disinfection and hygiene. The OEM project management teams are experts inproduct variation and combination, pharmaceutical contract manufacturing, andproduct development. Along with additional support such as analytical services, reg-ulatory support, and a professional customer and logistic service, B. Braun OEM isable to provide system-built solutions for a successful business.

Visit B. Braun OEM Division at Stand 8D72, Hall 8. •

Annual Meeting in NYCFocuses on Industry TrendsConsidered one of the PharmaChem industry’s premier events, DCAT Week is held eachMarch at The Waldorf-Astoria Hotel in New York City. In 2009, more than 560 companies reg-istered for DCAT Week programs and events, including the DCAT Annual Black-Tie Dinner.

DCAT Week offers unrivaled opportunities to hold high-level strategy meetingswith customers and vendors in one convenient location—The Waldorf-Astoria.Combining tradition and elegance with the largest number and variety of suites inthe city, The Waldorf is the perfect place to schedule meetings and entertain guests.

During the week, attendees catch up on industry trends by attending DCAT Week’s top-tier education programs presented by industry experts. With no registration fee for DCATWeek, attendees sign up for only those programs that meet their business objectives.

DCAT member companies can take advantage of a variety of member benefitsduring DCAT Week, including reduced meeting and hospitality suite rates, preferredtable locations at the Annual Dinner, access to the Member Lounge and Cyber Café,as well as a variety of high-profile advertising and sponsorship opportunities.

Visit www.DCAT.org for all the latest DCAT Week and Annual Dinner information.While at the website, sign up for eDCAT, a weekly e-mail newsletter with informationon programs, speaker bios, and the much anticipated announcement of the AnnualDinner keynote speaker.

About DCAT—As the industry’s premier business development association, the Drug,Chemical & Associated Technologies Association, (DCAT) brings buyers and sellerstogether, offering services, programs and events designed to support the businessobjects of its membership. DCAT member companies represent the entire spectrum ofthe PharmaChem industry—from pharmaceutical, API, excipient, and dietary supplementsales and manufacturing to distribution, support technologies and packaging productsand services. •


Solving Compound Challenges,Management Issues Are New Client-Focused Services As part of its ongoing commitment to providing world-class customer service andsupported by a backbone of scientific excellence, Penn Pharma has launched twonew client services: SoluSove and Customer Portal. Listening to clients’ needs, know-ing the market, and anticipating and adapting to the constant challenges within thesector are fundamental in business success and the foundation of Penn Pharma.

SoluSove—Almost half of all new compounds in the development pipelines are BCSClass II drugs. This means they are highly permeable through biological membranesbut are poorly water soluble, posing drug absorption problems in the patient’sgastrointestinal tract. The prime objective for Penn Pharma’s new formulation serviceis to improve water-solubility and maximize oral bioavailability of these drugs.

SoluSove offers a number of techniques for increasing the water solubility oflipophilic compounds. These include salt selection, particle reduction, use of carrierssuch as solution formulations and self-emulsifying drug delivery systems, meltextrusion and granulation, and functional “bioavailability enhancer” excipients suchas Gelucire and Vitamin E TPGS.

Penn Pharma is working to ensure that it has a growing armoury of tools andtechniques to help clients with these “difficult” compounds.

Customer Portal—Penn’s new secure online inventory management tool will allowclients to access real-time inventory information concerning their excipients, activepharmaceutical ingredients (APIs), packaging materials, and finishedproducts/clinical packs through the use of barcoding technologies. Clients can viewtheir inventories held at Penn Pharma 24 hours a day, 365 days per year. Informationwill be “live,” showing the progress and usage of their materials.

Innovating links to third-party courier websites will allow despatch information tobe brought to the portal and enable customers to track their despatches from PennPharma to the final destination. The portal will allow a centralized repository of data,enabling traceability of materials irrespective of where they are in the supply chain.

The enterprise resource planning system (ERP) will be fully validated to complywith GMP and CFR21 Part 11. Penn Pharma will be the first company to validate theSage 500 ERP software package in Europe.

Visit Penn Pharma at Stand 8D41. •

Shanghai Sourcing Operation LaunchedLeading contract research organization, Syntagon is expanding its global presenceby opening a facility in Shanghai. The expansion will further improve Syntagon’s rawmaterial sourcing capabilities, often a considerable cost element in clinical APIproduction.

“Our Shanghai office will allow us to source high-quality raw materials atcompetitive rates. Savings we will then be able to pass on to our clients,” saidSyntagon CEO Michael Lofthagen.

The acquisition of raw materials tends to represent a significant part of theoverall costs of conducting clinical trials. Syntagon’s Shanghai offices will haveaccess to a broader choice of suppliers and an immediate contact that will allowSyntagon to deliver materials more rapidly at more attractive prices.

The Shanghai offices will complement Syntagon’s existing operations inSödertälje, Sweden, and Riga, Latvia.

Syntagon’s process development expertise, analytical chemistry, andcrystallization services are tailored for all client types—from single-product start-upsto global pharmaceutical groups.

A leading Scandinavia-based drug development partner, the company developscompounds from lead optimization to phase II clinical trials using the latesttechnology and equipment combined with a solid quality system.

Visit Syntagon at Stand 8A28. •


Addressing the Challenge of PoorlyInsoluble CompoundsWhile the preferred route of drug administration is oral dosing, many compoundsthat may provide effective therapy either cannot be delivered in this way or aredelivered sub-optimally in pill form.

Biorise technology from Eurand, a specialty pharmaceutical company thatdevelops, manufactures, and commercializes enhanced pharmaceutical andbiopharmaceutical products based on its proprietary technologies, has overcomethis problem through its ability to transform a water-insoluble compound so that itcan be absorbed and provide effective therapy.

“Many compounds are highly efficacious at their therapeutic target, but theycannot be dosed orally,” said Stephen Perrett, Eurand’s VP of portfolio development.“Biorise renders drug substances in a form that is able to pass into the body whenswallowed. The chemical nature of the drug is not changed, so its original efficacyand safety remains relevant. The final product is a dry powder that can be deliveredeasily as a capsule or tablet.”

The Biorise process transforms drugs to a nanocrystalline or amorphous state. Thedrug is prevented from reverting back to its original insoluble crystalline formthrough the use of stabilizing materials, which are already used in many marketedpharmaceutical products. The process does not necessitate the introduction of anysolvents or unapproved materials and does not expose the drug to heat stress.

Biorise has important applications for existing drugs. Maximizing bioavailabilityreduces the amount of drug needed for equivalent therapeutic effect, making theproduct safer and more likely to have a consistent therapeutic effect. Biorise canalso increase the speed of drug absorption, which is particularly important in painrelief. The technology is commercialized in Europe by Novartis in Mesulid Fast, a fast-onset formulation of the NSAID pain-reliever nimesulide.

Building on its Biorise technology, Biorise focuses on sustained releaseapplications of poorly soluble drugs. This innovation has already opened a route forthe oral delivery of many compounds.

Visit Eurand at Stand 7C32. •

Advances in CustomManufacturing ServicesFounded in 1946, Fuji Chemical Industry (FCI) has been providing its own developedproducts and custom manufacturing services (CMSs) worldwide since its inception.Through proprietary technologies and specialized capabilities, FCI supports andaccelerates technologies and commercialization of therapeutics discovered anddeveloped by innovator drug companies (IDCs). This has made FCI a market leaderfor APIs and drug product intermediates (DPIs), particularly for small molecules.

FCI has differentiated itself from other companies in the CMS market for APIs andDPIs in the following areas: • Integration of Chemical Synthesis Capabilities and Spray-Dry Technologies: FCI

has been offering CMSs with open-cycle spray dry (OSD) for the aqueous feedsystem for more than 40 years. Responding to demand for solid dispersiontechnology to enhance solubility and bioavailability of poorly-soluble drugs, FCIintroduced closed-cycle spray dryers (CSD) for organic solvent-feed system in1998. FCI also supports Process Developments for APIs and DPIs from bench scaleto commercial scale in compliance with cGMP.

FCI maintains a unique position by offering a combination of chemicalsynthesis capabilities and spray drying activities performed and completed at thesame site.

• Large Database: FCI has built a large database of molecules related to spray drystudies and acquired a library of NCEs developed by collaborating with world-leading IDCs. This database furnishes an efficient and effective performance of itsservices, and forms the basis for route selections, process developments, andanalytical services, as well as the scale-up and optimization developments.

Visit Fugi Chemical Industry at Stand F66, Hall 7.•

A D V E R T I S M E N T


Low-Cost Approach to AsymmetricSynthesis Introduced

Prof. Takemoto of Kyoto UniversityJim Birnie, Custom Synthesis Business,

Sumitomo Chemical Europe

The area of asymmetric organocatalysis is an active field, with recent publicationsfrom Scripps Research Institute, Oregon University, Princeton University, University ofNew Mexico, and Kyoto University.

Sumitomo Chemical, in conjunction with Professor Takemoto of Kyoto University Japan, has built on the Chiral Chemistry portfolio to produce a range of aminothiourea catalysts that activate both nucleophile and electrophileconcurrently. These dual catalysts are efficiently used for asymmetric Michaeladditions, Mannich reactions, hydrazination, and aza-Henry reactions.

Synthesis of such catalysts has allowed highly enantioselective Michael addition of various nucleophiles such as 1,3-dicarbonyl compounds to nitroalkenes for the synthesis of asymmetric gamma amino acids, cyclopropanes, indolines, and pyrrolidines. The application has been extended to enantio and diastereoselective double Michael additions to provide ranges of optically active cyclohexanones. The same catalysts have beenused to prepare novel asymmetric piperidines, piperdinones, and cyclopropylderivatives.

Application of the aminothiourea catalysts to the Mannich reaction of various 1,3-dicarbonyl compounds has been particularly successful, providing access to a rangeof unnatural beta amino acids and 1,3-amino alcohols.

Similarly, the aza-Henry reaction with N-Boc imines provides a range of precursorsof chiral diamines and alpha amino acids.

Lastly, similar thiourea catalysts are available, which activate organoboronicacids, for Petasis-type addition to quinolines and conjugate additions to enones.

Enantiomers of aminothiourea catalyst are already scaled up to multi kg quantity. Visit Sumitomo Chemical at Stand 3A64, Hall 3. •

Advantages of Online Tube Labeling To meet the requirements of global supply chain, Almirall Hermal has installed onlinetube labeling equipment. With this equipment, blank plastic and aluminium tubes up to200g can be labeled prior to the filling of the tube as part of the online filling process.

With the help of online labeling capabilities Almirall Hermal can handle complexproduct portfolios and small run sizes in an economic way. The company can alsosupport launches and layout changes without major lead times.

Online labeling can offer various competitive advantages, including: • Higher flexibility• Competitive prices for smaller SKUs• Reduced lead times• Increased speed to market• Reduced stock levels for packaging materials• Less restrictions for design and layout complexity• Reduced write-offs with design changesVisit Almirall Hermal at Stand 8D10, Hall 8. •


Benefits of MagneticChemistry

ODT Technology Leader Intros New Tablet

SPI Pharma, based in Wilmington, DE, anda leader in oral dispersible tablet (ODT)technologies with its patentedPharmaburst and Pharmafreeze platforms,recently launched Pharmaburst 500.

Using proprietary technology withsuperior organoleptics, Pharmaburst 500 is expected to raisethe bar of performance and economics that formulators havecome to expect from a quick-dissolve dosage form.

Studies show that Pharmaburst 500 outperforms all of itsdirect competitors with respect to product functionality andorganoleptics. Easy to use, cost-effective and readilyformulated with various actives to make robust orally

disintegrating tablets (ODTs), the finished ODT can bemanufactured internally rather than through outsourcing.

Pharmaburst was the first off-the-shelf, patented, co-processed ODT excipient system introduced in the pharmaceuti-cal market and is still the only ODT excipient system included inthe US FDA’s Inactive Ingredient Guide (IIG List). It is now beingused worldwide in a variety of new and generic drug applicationsby leading multi-nationals and several top generic companies.

Oral dispersible drugs containing Pharmaburst have beensuccessfully launched in regulated and developing markets forindications such as migraine, allergy, analgesics, anxiety,oncology, schizophrenia, depression, and Parkinson’s.

Visit Pharmaburst at Stand 10E26. •Imagine having to separate a preciouscomponent or a toxic by-product from acomplex mixture or process stream.TurboBeads technology hasdemonstrated the methodology fordoing this to the entire magneticchemistry.

The company’s magnetic chemicalsgive the possibility to move drugs,antibodies, catalysts, noble, and heavymetals by pure magnetic forces. Usingthis method bypasses costly and tediousseparation processes such aschromatography and extraction.TurboBeads are compatible with mostsynthesis conditions, including allsolvents and harsh conditions, allowinga hassle-free incorporation of thetechnology into standard organicchemistry procedures, from a laboratoryscale up to production level.

Visit TurboBeads at Stand NB420. •

CRO Focusing onGrowthSolid Form Solutions is a leading globalcontract research organization (CRO)providing the pharmaceutical industrywith solid-form screening anddevelopment services. SFS has grownfrom a small screening outfit into acompany that is fully capable ofsupporting solid form developmentfrom early stage through scale-up andmanufacture. The company’s reputationhas seen its client base growdramatically over the past 18 months toencompass a range of companies, fromsmall biotechs to big pharma.

The year ahead for SFS holdscontinued expansion with the companyhoping to open a small syntheticchemistry operation to support itsscreening services.

Visit Solid Form Solutions at Stand7G76. •


Contract ManufacturerImplements Lean SolutionsThe pharmaceutical industry faces unprecedented challenges relating to patentexpiry, pricing, and regulatory pressures. In light of this, companies will have tostreamline their supply chain to be globally competitive and realize performanceimprovements with a direct impact on profit and loss (P&L) in the short term.

One of the methods for realizing these cost savings is with business processexcellence (BPE), which combines the best aspects from existing performanceimprovement methods, such as Six Sigma or Kaizen, into a new approach.

The basic methodology for implementing BPE involves a closed-loop approach. Dataassessment that is assembled in a systematic database is the first step. These are keyperformance indicators (KPIs) such as capacity utilization, conversion cost per unit,throughput time, and turnover rate forward. These KPIs have to be analyzed usingstatistical tools so a hypothesis can be developed about deviations or spots ofunderperformance. Any hypothesis needs to be verified to find the right conclusion, andthe saving potentials identified in the conclusion step have to be converted to actions.Their implementation has to be monitored closely by clearly defined milestones.

In Boehringer Ingelheim’s contract manufacturing facility, BPE is used to analyzethe manufacturing process of clients’ products with a focus on reducingmanufacturing costs while improving process robustness and process stability. Whena process is analyzed with BPE, the knowledge is then transferred to documents andno longer committed to the memory of employees. BPE covers yield analysis,throughput times, and efficiency parameters. Based on the outcome of theassessment, a process improvement plan will be established and verified thoroughlyregarding regulatory feasibility.

The client gains the advantage of being able to compensate for inflationary costincreases driven by external factors such as wage settlements, energy, andconsumables. Ultimately, this guarantees a safe planning horizon for the business.

Visit Boehringer Ingelheim at Stand 8F54, Hall 8. •

Innovative Tebletting ProcessesIntroducedCargill Pharma’s two new polyol excipient applications, plus an extension to thecompany’s broad pharma polyol portfolio, are the result of another year ofinnovation at the Cargill Pharma Application Centre in Vilvoorde, Belgium.

In a significant development for pharma manufacturers, Cargill has created a newand valuable way of using Zerose erythritol as a tabletting excipient. A new patent-pending wet granulation process, using Zerose as a diluent, makes it possible tomanufacture chewable tablets that benefit from Zerose’s taste-masking properties,which is very valuable for products containing bitter and unpalatableactives. Additionally, Zerose erythritol is officially zero calorie, is non-cariogenic, andhas a high digestive tolerance—all qualities ideally suited to its utilization in oraldosage formulations.

The new process is more suitable for moisture sensitive actives due to its use ofC*PharmIsoMaltidex isomalt as a binder. Both Zerose and C*PharmIsoMaltidex arenon-hygroscopic, permitting the production of tablets with a low hygroscopic profile.

C*PharmIsoMaltidex also features in this year’s second announcement fromCargill Pharma: another new patent-pending tabletting process using isomalt as anexcipient. This will enable manufacturers to benefit from the sweet taste, lowhygroscopicity, and non-cariogenic properties of C*PharmIsoMaltidex in tabletproduction.

Cargill will also unveil a new crystalline pharma grade of maltitol,C*PharmMaltidex CH, to complement the existing liquid offering. This polyol has asweet taste, low hygroscopicity, and is non-cariogenic. It is ideally suited to thecreation of improved coatings on, for example, medicated chewing gum.

Cargill Pharma’s increasingly extensive portfolio of products and innovativesolutions, with the services and expertise that support them, underline Cargill’scommitment to being one of the most trusted, dedicated and experienced pharmaingredient suppliers.

Visit Cargill Pharma at Stand 4B55, Hall 4. •


Cambridge Major LaboratoriesCompletes Investments

Cambridge Major Laboratories dedicated its new large scale Active PharmaceuticalIngredient (API) manufacturing facility in Germantown, WI, U.S. in July. The state-of-the-art facility provides a high quality, U.S.-based API supply option for thepharmaceutical and biotechnology industries, and is in response to CML’s need forlarger capacity fueled by its growing pipeline of developmental and commercialmanufacturing projects.

The facility is designed with six Good Manufacturing Practice (GMP)manufacturing suites capable of producing multi-ton quantities of APIs andadvanced pharmaceutical intermediates. The installed capacity totals 18,000 gallons(70 cubic meters), with expansion capability for an additional 30,000 gallons (120cubic meters). In addition, CML has invested in thermal oxidizer technology to ensurecompliance with EPA and DNR air quality standards, as well as a large volume tankfarm to enable more efficient and cost effective use of solvents.

Recently, Cambridge Major also completed multi-million dollar investments in itsdevelopment facilities in the Netherlands, including new R&D and analyticallaboratories, and additional pilot plant capacity. These investments will add morethan 40% to CML-Europe’s capacity and enable that facility to produce up to 100s ofkilograms of APIs and intermediates

CML highlights its strategy to be the premier, western-based supply option to thepharmaceutical industry. The impressive history of growth is built on the foundationof a strong development chemistry team, with proven problem solving capabilitiesand a clear commitment to project management. The new investments in largerscale capacity remove any risks associated with late stage tech transfer and providea guarantee to clients of complete supply chain security, and product quality fromWestern-based assets. CML’s three development centers will funnel products to thenew facility for scale up to hundreds of kilograms or ton scale.

Visit Cambridge Major Laboratories at Stand 10E59. •

The Key to ANDA SuccessThe key to quick ANDA approval is to ensure that the API is developed meticulously,that all the development and manufacturing procedures strictly adhere toestablished cGMP compliance standards, and that quality standards are documentedprecisely to comply with FDA and all other governing bodies when needed.

This is a large and time-consuming task for any drug manufacturer. Most APImanufacturers are not located near the drug manufacturer site, which makes italmost impossible to assure cGMP compliance without working through anagent/broker that has qualified regulatory personnel and offices in the same countryas the API manufacturer. For better results, finished dosage manufacturers would bewell served to have an API supplier close to the manufacturing source and to partnerwith one that has a proven track record of success.

That’s where Chemwerth comes in. It has a wealth of knowledge about cGMPdocumentation and can avoid problems to quickly move applications through thesystem. Visit Chemwerth at Stand 5A16. •


Latvian Pharma Highlights Value ofIntegrated Services

Manufacturer, Distributor DevelopOptical Partnership Geymonat, a highly experienced and widely known company working in thepharmaceutical market since 1928, has a comprehensive product list of foodsupplements, medical devices, and dermocosmetics distributed both in the nationaland international pharmaceutical markets.

Geymonat is cooperating with such companies as Novartis, Procter & Gamble,Vifor International, Boeringher Ingelheim France, Ferrer-Trommsdorf, Kanebo-Organono and Smithkline. Continuously investing in research and development,Geymonat opened in 1993 a new center for the biotechnologies. Geymonat hasdeveloped new technologies such as pellets, foam and vaginal mucoadhesivepolymers, and offers services of contract manufacturing (solid orals, sterileampoules, ointments, suppositories, ovules, and liquids for oral use).

Marshal Intergroup, a manufacturer and distributor in the optical market since the early 1990s with a focus on contact lenses and contact lens care products, launched Marshal Pharma in 2007 with a focus on the distribution ofoptical goods in the pharmaceutical market. One of its initial projects was to create a unique eye-corner display in pharmacies. It was launched in numerouscountries.

In September 2008, officials of Geymonat and Marshal met in Germany at the fairExpopharm fair and subsequently signed a partnership agreement in 2009.

The partnership aims to create health and beauty departments insidepharmacies that comprehend such optical products as contact lenses, solutions,sunglasses, reading glasses, and dermo-cosmetic products—as well as such femalespecialty products as volumizing lipstick, lifting-effect face gel and spray for heavylegs. The team will introduce innovative products in the upcoming months.

Visit Geymonat and Marshal at their shared Stand 10C26, Hall 10. •

Expansion Project Increases Capabilitieswith New GMP Analytical LaboratoryAs part of its multi-million dollar expansion project, PharmaCore has built and is inthe process of starting up its new GMP Analytical laboratory.

The GMP Analytical laboratory will provide analytical support through all phases ofin-house contract API production to eight separate production suites. Formerly em-ploying three suites with small-scale capabilities (1-3 Kg maximum batch) for Phase 2clinical API production, the expanded 40,000 sq. ft. facility will have the capability toproduce 50+ Kg material batch sizes and Phase 3 materials. From testing incomingraw materials against strictly controlled standards, through in-process and intermedi-ate testing support, to GMP release of final product, PharmaCore’s GMP Analytical Lab-oratory will provide state-of-the-art support to its growing contract API business.

Four GMP Analytical Laboratory scientists include two PhDs and have a combinedtotal of more than 70 years of experience in a wide variety of analyticalmethods/product settings. A fifth scientist is expected to be added soon.

PharmaCore is also planning to make pharmaceutical analytical servicesavailable on a contract basis. In this vein, PharmaCore’s GMP Analytical Laboratorywill focus on the API arena and will provide expertise in and support for: routineanalytical tests (including USP compendial), analytical methods development andvalidation, analytical methods transfer, cleaning validation, and consultation.

PharmaCore’s capabilities will initially include several HPLCs and autotitrators, a GC,an IR, a DSC, and several other instruments. Its instruments undergo rigorousqualification prior to use and on an ongoing basis to assure the highest quality results.

Finally, an upgrade of its chromatography data systems is underway with the mostcurrent version of software available. It has networked all major analyticalinstrumentation and is installing and qualifying Agilent’s Enterprise ContentManager (ECM) as its data management system. Not only will this allow for a fullaudit trail, but also make data available immediately and ensure its integrity andsafety. The future uses of the ECM system are being planned now and include fullreport generation (such as for CMC, IND, DMF submissions), electronic documentmanagement (batch operating procedures, SOPs, etc), and instrument calibrationand PM scheduling. Visit PharmaCore at Stand USP092. •

A Latvian-based leading pharmaceutical company, Grindeks provides extensiveknowledge and experience in research, development, manufacture, registration, andsales of original cardiovascular and anti-cancer products, generics, and active phar-maceutical ingredients, with sales in more than 40 countries.

Grindeks is a vertically integrated company and offers a fully integrated set ofservices, from API development and manufacture to the development, manufacture,packaging, and distribution of finished dosage forms.

The company’s integrated capabilities include:• Research and development services, e.g., patent extension feasibility studies for

brand-name products and development of brand-generics• Complicated, multi-stage synthesis of APIs, particularly for niché pharmaceutical

products• API manufacturing for clinical studies in accordance with cGMP standards and

specific customer requirements• Commercial API manufacturing, including development of registration documen-

tation (ASMF)• Development of finished dosage forms technology, validation of the manufactur-

ing process and analysis methods, and development of drug registration docu-mentation

• Customized contract manufacturing of final dosage forms (tablets and capsules)in a new manufacturing plant opened in 2008

• Full development of drug registration documentation (in CTD and eCTD format inaccordance with EU and CIS requirements), registration, process management, andcoordination.

• Compliance with the highest international quality standards (GMP, GLP, GCP, GDPand ISO)

• Competitive pricing• Large sales network in Russia and other CIS countries and deep local-market knowl-

edge, as well as its advantageous geographical location saving logistics costs

Grindeks invests in modernizing its manufacturing infrastructure and technologies.Significant resources have been invested to introduce and establish internationalstandards in the quality assurance system, innovative laboratory equipment, andmanufacturing facilities.

Visit Grindeks in Stand 10G41, Hall 10. •


New Pharma-Grade SucraloseAvailablePolymed Therapeutics has been aleading global supplier of APIs for morethan a decade. The company has filed inexcess of 30 Drug Master Files to U.S.,Canadian, and EU health authorities.Committed to the highest qualityproducts and service, Polymed alsooffers competitive pricing.

Polymed is now offering a pharma-grade Sucralose, which is backed byconfirmed U.S. Patents.

Additional pharmaceutical-gradeAPIs produced by Polymde include:Azacytidine, Bortezomib, Docetaxel,Topotecan, Oxaliplatin, Irinotecan,Paclitaxel, Decitabine, Cholecalciferol(Vitamin D3), Ergocalciferol (Vitamin D2),and Vitamin D Analogs such asDoxercalciferol, Calcitriol, Calcipotriol,Paricalcitol, etc.

With completion of the company’sthird cGMP facility in late 2007, Polymedcan custom manufacture APIs andintermediates for a broad range ofneeds.

Visit Polymed Therapeutics at StandUSP15, Hall 4. •

Executive Appointments Support Codexis GrowthCodexis has appointed David Anton as senior VP of research anddevelopment, with responsibility for R&D activities in both thebioindustrials and pharmaceuticals businesses. Anton was previ-ously VP, research and development for Codexis Bioindustrials.

The company also announced that John Grate, previouslysenior VP, technology and innovation and chief technologyofficer, has assumed the newly-created position of senior VP,science and innovation and chief science officer.

Anton joined Codexis in 2008 after a 25-year career withDuPont, where he was the global business lead for develop-ment of DuPont’s advanced biofuel, butanol, as Venture Man-ager, Biofuels. He joined DuPont in 1983 and held a variety ofsenior research management positions across bioprocessing

and biocatalysis. He holds a bachelor’s degree in biochemistryfrom the University of California, Berkeley and a Ph.D. in bio-chemistry from the University of Minnesota. He served as amember of the joint DOE/USDA Biomass Research and Devel-opment Technology Advisory Committee from 2006 until 2009.

Grate joined Codexis in 2002. Previously, he held variousR&D leadership positions during 20 years at Catalytica, includ-ing founding VP, research and development for the subsidiaryCatalytica Pharmaceuticals until its acquisition by DSM in 2001.Grate received his bachelor’s degree in chemistry from MiamiUniversity (Ohio) and his Ph.D. in chemistry from the Universityof California, San Diego. He is a registered U.S. Patent Agent.

Visit Codexis at Stand 5F24. •

German ProductionFacility UnderConstructionDr. R. Pfleger, a Bamberg, Germany-based med-sized pharmaceuticalcompany established in 1945, is ownedby the Doktor Robert PflegerFoundation, an organization thatdirectly supports basic medical research,as well as charitable and social causes.

Dr. R. Pfleger provides acomprehensive service package basedon solid experience and technicalknowledge in drug research andproduction. Leading pharmaceuticalcompanies regularly contract Dr. R.Pfleger to manufacture their products,having relied on Pfleger’s capabilitiesfor years more than 60 years.

Recently, Pflegers started a newfacility that includes a production andpacking department, R&D facility, andquality control center. The new facility,under construction next to the existingmanufacturing in the new building, willbe operational at the end of 2010.

Visit Dr. R. Pfleger at Stand 8D65,Hall 8. •


$71 Million HPAPI InvestmentsNear Completion

The final quarter of 2009 and first quarter of 2010 will see the completion of threenew SAFC Pharma facilities designed to augment the company’s existing capabilitiesin high potency API (HPAPI) manufacturing, representing a total investment of $71million.

In Madison, WI, SAFC Pharma purchased 15 acres near its existing HPAPI facilityand has constructed a 45,000 sq. ft. manufacturing plant, housing commercial-scalereactors capable of producing HPAPI batch sizes up to 4,000 L. Designed to maximizeefficiencies and safe handling in high-potency development and adhere to CategoryIV standards, the highest guideline for HPAPI handling and containment, the site willseek Safebridge Certification upon its completion.

The facility includes state-of-the-art development laboratories, a 150 L mini-processing plant, and two large-scale cGMP manufacturing suites with reactors up to4,000 L. The $30 million site features specially designed quality control laboratories,a potent compound packaging area, warehouse and office space, and additionalspace for expansion.

Also nearing completion is a $12 million expansion at SAFC Pharma’s nichébiologics production facility in Carlsbad, CA. Two fully segregated state-of-the-artviral vector and vaccine manufacturing suites have been built, employing the latestin disposable bioreactor technologies and enabling SAFC Pharma’s viralmanufacturing to increase to commercial-scale quantities. The new suites add 8,000sq. ft. of manufacturing space and enable 100 L batch production in stirred tankbioreactors and 1,000 L batch manufacturing in disposable bioreactors. Theexpansion adds to the current 44,000 sq. ft. site and is Biosafety Level 2 compliant,allowing manipulation of human pathogens.

Complementing these two expansions is a 50,000 sq. ft. four-story extension ofthe company’s fermentation capabilities at its Jerusalem, Israel production sitedesigned to extend the range and scope of coverage in niché technologies for theAPIs and biologics sectors.

Scheduled for completion in early 2010, the $29 million investment will enableSAFC Pharma to provide process development and cGMP manufacturing forcustomers needing large-scale, high-potency, toxic or hazardous drug substancesthrough fermentation. Assets will include 1,000- and 4,000-L fermentation tankcapacities for bacteria, fungi, and yeast.

Advances in clinical pharmacology and oncology research over the past decadehave resulted in annual double-digit growth and significant opportunities in theHPAPI market, and with SAFC’s being at the forefront of this technology, it ispositioned for future growth with its significant investments in expanding capabilityand capacity. Vist SAFC at Stand 3B56 •

Injectables Manufacturer Focuseson InnovationGland Pharma is an India-based injectables manufacturing company with world-class facilities that have maintained US FDA approval since 2003. Being pioneers ofHeparin & LMW Heparin technology, Gland was the first company to establish a pre-filled syringe unit in India.

The company offers services such as contract manufacturing, productdevelopment, and contract research for products such as ampoules, vials, pre-filledsyringes, lyophylization, and bag filling. With a strong R&D team, Gland works withmany multi-nationals in areas covering product development to ANDA filings,supplying products to many generic injectable companies in the U.S.

Gland’s GMP production capabilities include:• Two Groninger Syringe lines capable of filling 0.5ml to 50ml, up to 200,000/day• Three Vial lines capable of filling 2ml to 100ml, up to 400,000/day• Two Ampoule lines capable of filling 1ml to 50ml, up to 400,000/day• Three Lyophilizers capable of handling 100,000 units/cycle• Cartridge line and bag line• Able to maintain success through training, documentation, and effective hiring,

Gland has become recognized experts in multiple therapeutic areas, includingCNS, sardiovascular (hypertension and congestive heart failure), oncology(biological response modifiers and supportive therapy to chemotherapy), andtopical formulations (including eye-drops and transdermal application systems)Gland’s areas of on-going R&D include:

• Preclinical services• Preformulation services• Formulation development• Method development and

validation• Quality control testing• Microbiology services• Stability services• Lyo cycle development• Lyo manufacturing• Dossier compilation• Clinical batch manufacturing

Visit Gland Pharma at Stand 7J52. •


New UK Facility Enhances API TechnologiesPiramal Healthcare’s recent relocation of its UK Biocatalysis Division to custom labfacilities in Wilton, Teesside underlines the company’s focus on a range of strategicAPI technologies and offers greater flexibility and expansion potential than theprevious Billingham facility.

Biocatalysis technical director Bob Holt said the mission is to target customeropportunities in both developmental compounds for clinical trials and launchedproducts, which can be made more cost-effectively using biocatalysis-basedsynthesis.

“Biocatalysis meets both the cost and green agendas,” Holt said. “The superiorselectivity of enzyme-catalysed reactions—including stereoselectivity,chemoselectivity, and regioselectivity—give cost advantages over chemical routes.These result from better reaction yields and reduced need for purifications, hencelowered energy use, waste, and environmental burden.”

Piramal’s biocatalysis offer combines route invention, biocatalyst discovery, andprocess development in the UK, as well as rapid scale-up and manufacture in the UKor India-based facilities according to customer need. The Wilton labs are optimizedfor activities such as molecular biology, microbiology, enzymology, biotransformation,and analytical chemistry.

Enzyme production and biocatalysis manufacturing projects located withinPiramal’s extensive in-house facilities in India will be managed by a similardedicated unit.

Holt leads one of the industry’s most experienced biocatalysis teams, offeringcustomers a proven track record in taking a concept through to manufacture at tonscale within 12 months. The in-house culture collection in UK/India exceeds 30,000species, with custom biocatalysts identified from expertise in microbiology andgenetic engineering. Crucially, biocatalysis can be fully integrated with chemistry intoan overall synthetic route.

Visit Piramal Healthcare at Stand 8A58. •

Labeling Machine Continues Record of Quality

With a firm commitment topharmaceutical serialization,Marchesini Group offers the market“track and trace” solutionsdeveloped specifically and tested incooperation with major multi-national enterprises. The companyhas already placed many modularsolutions that can be integrated intoexistent packaging lines.

At CPhI, Marchesini will befeaturing the labeling machine NeriBL400 VTE XL. This machine applies

“tamper evident” vignettes and self-adhesive seals on the product, as well as printscoded for tracking and verifying pharmaceutical products via appropriate scanningsystems.

With a balcony structure, it is ergonomic and fully accessible, especially in termsof cleaning management and supervision of the production process. It is alsoequipped with a positive step carton conveyance system (by means of toothed belts)that ensures totally “fail safe” operation and guarantees “grade c” printing quality,requested by European and American standards. These features are associated withthe well-known label application precision of Neri machines, size change speed andaccuracy, and high production rates of 400 cartons per minute.

While accommodating three labeling heads to apply a vignette on the top sideand two seals (tamper evident) on the side corners of the cartons, it also printsDatamatrix codes and alphanumeric equivalents in three positions (on the top faceand on both flaps of the carton).

Visit Marchesini Group at Stand 8F05. •


New Pharmaceutical DevelopmentServices OfferedTo compliment its existing profile, Encap now provides a full range of pharmaceuticaldevelopment services from pre-formulation to prototype formulations for clinicaltrials. Encap can tailor services to meet clients’ individual needs, whether it be arapid first-in-man development program or a formulation optimized withcommercial manufacturing in mind.

Among the new pharmaceutical development services are such offerings as:• CMC consultancy• Analytical method transfer and development• Pre-formulation and formulation development• Clinical trial manufacturing• Stability services• QP release• Product registration support

Encap can support clients for all their clinical trial manufacturing needs (Phase I toPhase IV) and for full commercial scale manufacturing. It provides clients with simple,scalable oral formulations designed to promote a successful clinical outcome in:• Bioavailability enhancement using liquid- and semisolid-filled hard capsules (lipid

formulations including SEDDS and SMEDDS)• Colonic delivery (NCEs, peptides, and proteins) • Immediate and controlled release• Highly potent and cytotoxic APIs• Hygroscopic and oxidation sensitive compounds• Crystalline and amorphous materials (independent of particle size, shape, and

density)

Encap is a specialist contract manufacturing and development organization and aleading expert in liquid-filled hard capsules. For more than 20 years, Encap hasprovided clients in the global pharmaceutical, biotechnology, and nutraceuticalindustries with a range of services designed to support them through developmentto commercialization.

Encap’s experienced team has helped hundreds of clients get their moleculesquickly and cost effectively into clinical evaluation, while minimizing the risk offormulation failure. The company’s state-of-the-art, UK-based facility is the world’slargest for the manufacture of liquid-filled hard capsule pharmaceutical productsand is approved by the FDA and licensed by the MHRA.

Visit Encap at Stand 8F53. •

Science of Synthesis Poised for Update

Beginning in 2010, the organic chemistry reference series Science of Synthesis will becontinuously updated with high-quality content using clearly defined criteria formethod selection as well as established editorial processes. The Editorial Board, inconjunction with the volume editors and authors, will review the whole field ofsynthetic organic chemistry as presented in Science of Synthesis and evaluatesignificant developments in synthetic methodology.

The series will be edited by E. M. Carreira (Zurich, Switzerland), C. P. Decicco(Princeton, USA), A. Fuerstner (Muelheim, Germany), G. A. Molander (Pennsylvania, PA),P. J. Reider (Princeton, NJ), E. Schaumann (Clausthal-Zellerfeld, Germany), M. Shibasaki(Tokyo, Japan), E. J. Thomas (Manchester, UK), and B. M. Trost (Stanford, CN).

A list of strict criteria for method selection will guide the updating process toguarantee that only the best and most reliable synthetic methods are included inScience of Synthesis. Authors who are renowned specialists in their respective fieldswill add new methods and new (or completely revised) product (sub)classes.

The updating procedure will be continuous and new content will be added to theelectronic version in four releases per year. Science of Synthesis will continue to bethe most up-to-date evaluated electronic reference work available, emphasizing themost significant developments in synthetic methodology.

Science of Synthesis will give convenient access to a century of synthetic organicchemistry starting with the first volume of Houben–Weyl published in 1909 throughto groundbreaking methodology added immediately upon validation by experts. Theelectronic version’s intuitive interface will adapt in keeping with the latesttechnological developments and will enable chemists worldwide in both academiaand industry to solve complex synthetic problems.

Visit Thieme Chemistry at Stand 5A29. •

Market Leader Specializes in Proprietary TechCytec, a global leader in phosphine gas and phosphorus derivatives, offers a widerange of effective process aids and building blocks for pharmaceutical applications.

The company also specializes in the manufacture of proprietary technology. If itcan be made from PH3 or PCl3, Cytec has the experience to make it happen.

With 50 years of experience in development and manufacture of phosphorus-based specialty chemicals, Cytec has developed industry-leading competencies inthree primary areas: phosphine and chlorophosphine technology, productdevelopment, and manufacturing excellence. Visit Cytec at Stand USP057, Hall 4. •


Joint VentureOpens U.S.-based PlantPCAS and Nanosyn have entered into ajoint venture for a cGMP kilolab in SantaRosa, CA, that will offer fully integratedcustom chemical services from discoveryto commercialization.

“The formation of this joint venturewith such a reputable partner as wehave found in Nanosyn allows us to placecritical preclinical and clinical trial APIsynthetic capabilities nearer to ourclients in the U.S.,” said Christian Moretti,chairman of PCAS.

The PCAS-Nanosyn facility has beenfully operational since Nanosynacquired the physical assets of SeresLabs last March and retained itsexperienced staff with a 30-year historyas a FDA-registered cGMP site.

As part of PCAS-Nanosyn strategy tobe the premier provider of high-qualityand cost-efficient services for thepharmaceutical and biotechnologyindustries, the plant will provide servicesfrom the six (GMP) suites, two of whichare certified as Class 10,000 cleanrooms. The joint venture plans to furtherexpand the site by upgrading its existingR&D and analytical capabilities whileadding new advanced capacities.Additionally, customers will furtherbenefit from the chemical andanalytical resources within the parentcompanies and the ability to seamlesslytransfer projects for larger scale toPCAS’ four FDA-inspected commercialplants in Europe.

“This suite of cGMP solutions as aresult of this partnership…is a naturalextension of Nanosyn’s highly successfuldiscovery services into processdevelopment, scale-up, and supply ofpreclinical and cGMP clinical trialquantities of APIs,” said Nikolai Sepetov,president and CEO of Nanosyn.

Visit PCAS at Stand 4F60. •

Head of Corporate Development To Spearhead Market Trends

RohnerChem is intensifying its business activities in Europeanand U.S. markets to develop long-term partnerships withcustomers and establish networks, strategic alliances, andcooperations with partners and universities.

To achieve this aim, Andres Tschupp joined the company in Au-gust as head of corporate development. He is responsible foridentifying market trends, evaluating new business ideas andsegments, and establishing collaborations with partners withinthe pharmaceutical and various specialty chemicals industries.

Tschupp has a long experience in business development at an executive level with Lonza in Switzerland and is agoverning board member of an international pharmaceutical company. Previously, he founded and

grew a successful international life science company. Founded in 1906, RohnerChem is a Swiss-based custom

chemical manufacturer leveraging conventional chemistrywith expertise in several state-of-the-art technologies (e.g.,transition metal catalysis, polymer modification, and high-pressure/low-temperature reactions) to support customerswith unique and challenging manufacturing requirements forcomplex small molecules.

RohnerChem provides efficient technology transfermatched with customer responsiveness, operational flexibility,and rapid scale-up expertise to serve customers in the lifescience and specialty chemicals industries.

Visit RohnerChem at Stand 5E01. •

Pharma FeaturesLine-UpShenzhen Haibin Pharma, the biggestmanufacturer for meropenem API anddosage form, produces meropenem,imipenem and cilastatin sodium,biapenem, doripenem, 4aa, MAP, andGMP and DMF are also available. Visit Shenzhen Haibin Pharma at Stand5D40. •


New Bag Promotes Wound Healing

Treatment of lesions or bedsores is crucial. Healing occurs through the formation ofa connective tissue that becomes covered by the multiplication of the epithelialcells and the migration of these cells from the lesion’s borders to its center.Treatment is influenced by local factors as well as by systemic factors. The lesiontreatment can be altered based on the patient’s condition, the type of wound, andits evolution. The basic principle is to encourage the lesion’s recovery—respectingthe natural environment in which restoring, granulation, and re-epithelization takeplace—and to avoid conditions that could slow them down, such as humidity, pH, andtemperature variation.

Initiated and registered from Haemopharm’s Research and DevelopmentDepartment, the Washout bag for the cleaning of critical wounds allows a betterremoval of the inflammatory agents and possible residuals of previous medications.This tool promotes the reduction of bacterial colonizations, decreases the risk ofinfection, and speeds up the regeneration of tissues.

The bag can be filled with every kind of solution required for healing, includinggels. The Ringer Lactate is the best one because of the potassium salts content thatseems to promote cutaneous trophism.

Washout is a patent-pending product of Haemopharm Healthcare, a companycertified by UNI EN ISO 9001:2008 and UNI EN ISO 13485:2007.

Visit Haemopharm Healthcare at Stand 10G43. •

New Facility Accommodates Kilo-Scale SynthesisHamari Chemicals has more than 50 years experience in custom manufacturingand can produce in excess of 60 reactions on a commercial scale (50-5,000L). Thecompany’s Yonezawa production site has been FDA inspected and has extensiveexperience in API synthesis under cGMP conditions (for clinical studies andcommercial scale).

Hamari has more than 30 years of expertise in the synthesis of small to medium-length peptides, using solution phase technology. It has also recently invested insolid phase synthesis equipment to meet the growing market demand in this area.

The company has been further expanding its R&D facilities with additionallaboratory units and the construction of a kilo-scale laboratory to accommodatecGMP manufacturing of intermediates and non-GMP manufacturing of APIs. Kilo-scale synthesis and swift transition from lab to trial manufacturing are possible.Further, Hamari has invested in laboratory equipment for high-activity compounds(category 4).

Hamari has been providing custom manufacturing of high qualitypharmaceuticals in a reliable and flexible manner to meet the needs of customersin North America, Western Europe, and Asia. Whether looking for activepharmaceutical ingredients, intermediates, food additives, amino acid derivatives,or nutritional ingredients, Hamari can deliver quality products on time.

Visit Hamari Chemicals at Stand 4G01. •

New Device Enhances Cold Chain MonitoringLibero temperature monitoring device, manufactured by Elpro, provides newbenefits for the user, including speed, ease of use, higher specifications, reductionsin necessary validation work, and faster data access. Libero’s unique features andlow price have convinced major pharmaceutical companies and clinical trialorganizations worldwide to monitor with Libero.

The PDF Logger measures and stores temperature during the cold chaintransport. At destination, Libero is simply plugged into a USB port on any PC(Windows, MAC, or Linux). It automatically creates a PDF/A report with text, alarminformation, statistics, and a graphic line chart. Libero acts as a USB memory stick,and the PC will automatically show the file as a new- found drive. The evaluationreport can be viewed by Acrobat Reader, printed, or sent directly by e-mail.

Visit Elpro at Stand 8E30. •


Dedicated Firm Pursues DiscoveriesAmega Biotech, an umbrella organization located in Argentina and supportingindependent structures, allows a fully controlled process from the raw material (API)to finished product. Dedicated to the development of biopharmaceuticals, thecompany is also pursuing the discovery of innovative treatments in the areas ofoncology and infectious diseases.

It has developed in-house the innovative protein—PEG G-CSF—distinguishingAmega Biotech as the protein’s first Latin American developer and the companyplans to enter the world market as one of the pioneer manufacturers of the product.Company officials believe the achievement is a template for future development ofnovel proteins and builds on the strength of a fully controlled process that beginswith its research and development department.

This year, Amega Biotech is opening a new manufacturing site dedicated to theproduction of the human recombinant Erythropoietin in Santa Fe, Argentina. The site,constructed following cGMP standards, has a total of 4,500 sqm and producessignificant quantities of EPO meeting the highest standards.

Visit Amega Biotech at Stand 8BIO01 •

New Drugs on Basis of RecombinantProteins Being Developed

Hameln RDS has applied to the EuropeanUnion for structural funds to be used in aresearch program on new drugs on the basisof recombinant proteins.

New drugs on the basis of recombinantproteins have to meet the strictrequirements applicable to different types oftherapeutic strategies, i.e., biosafety,biocompatibility, stability, purity, andcharacterization. In order to bring such drugscloser to human applications, all of theserequirements have to be taken intoconsideration during the development

process. Hameln’s project is designed to develop and study an innovativepharmaceutical form.

Hameln RDS believes that the cooperation of academia and industry is crucial forthe success of this project and for the general future of the technology. This projectand following ones will be realized in cooperation with universities, establishing along-term cooperation between Hameln RDS and the academic sector.

Visit Hameln RSD at Stand D22, Hall 8. •

Recession Brings Opportunities

Sanyong Pharmaceuticals offers customers a partner to reduce costs across allaspects of their business, with specialty in natural extracts and solvent freeextracts/oils. The company can:• Identify the right partner for your India operations • Identify right sources for your raw materials from India • Identify right people for your India operations • Identify clinical research and regulatory data development partners in India • Conduct other pharma-related activity in India on your behalf.

Sanyong’s subsidiary, Rainbow Naturals, deals in bioactives for the pharma and foodprocessing industries. All the products are extracted using well advanced supercritical CO2 technology. The products can be used directly in formulations withoutfurther purification. Because these are the purest form of extract/oil, the productscan be directly filled in gel capsules.

Visit Sanyog Pharmaceuticals at Stand 10J08. •


Large-ScaleReactor ModulesLaunchesBuilding on the launch of the Labtrixsystem, Chemtrix launches a prototypeof its second product, Protrix, and thenew Plantrix reactor modules. While theLabtrix system is designed for R&D use,Protrix is for kg-scale production,making it unique in the market place.

With Protrix, it is possible to scale-upto 128 chips with four channels in eachchip, for a total of 512 channels inparallel. Protrix uses the same channelsas in Labtrix, and the same parameterscan also be used in Protrix to producesmall quantities up to kilograms per day.

Using this new system, the step fromR&D to production can be realizedwithout loss of time because the userdoes not have to develop new processparameters. With Protrix, it is alsopossible to investigate the idealparameters for ton-scale production,which is also possible with Plantrix. Thiscapacity to increase micro-reactor chipsfrom laboratory systems to g/mg scaleand then to ton-scale production is aunique innovation.

Visit Chemtrix at Stand NB408. •

ADD Features Drug Development ServicesADD Technologies, an independent and international phar-maceutical company based in Basel, Switzerland, delivers in-tegrated solid dosage form product development support andservices for products with a clear focus on multi-particulatedrug delivery systems.

Its activities comprise pre-formulation, formulation, and pro-cess development evolving within a global organization, processscale-up, submission batch manufacturing, production of clinicaltrial material, technology transfer, and cGMP commercial manu-facturing in group owned sites in Europe and the U.S.

ADD provides development services for multi-particulatedrug delivery systems of superior reproducibility and lowsystem variability, converts concepts for sustained and

extended release multi-unit delivery systems, time-releasesystems, site-directed systems, oral dispersible tablets, andtaste-masked preparations.

In addition to contemporary formulations and processingapproaches, it also provides proprietary processing technolo-gies, enabling solutions for unmet biopharmaceutical de-mands and new unique products.

ADD’s team of experienced scientists and experts form a know-ledge base with expertise to solve complex and challenging pro-jects. It has a successful track record in developing products from abroad range of categories, including new chemical entities, pro-duct line extensions, generic drugs, and over-the-counter products.

Visit ADD Technologies at Stand 3E40, Hall 3. •

Supplier OffersGlobal CoverageThrough its multi-territoryrepresentation of such leading chemicalmanufacturers as Air Products, Arkema,BASF, BP, Cognis, Eastman, GaylordChemical, Ineos and Rhodia, IMCDGroup is well positioned as a majorsupplier to the various markets ofchemical synthesis.

The company utilizes its Indian and Chinese affiliates to source high-quality, audited materials from leading Asian suppliers. IMCD’s pan-European infrastructure, with salesoffices in major European countries,facilitates a fast response to customersrequirements.

Among the core products IMCDsupplies are: acetonitrile, acrylonitrile,dimethylsulphoxide, alkylamines,mercaptans, thiols, diphenols,fluorinated intermediates and reagents, 2-methyltetrahydrafuran,acrylates, and precious metal catalysts.

Visit IMCD Group at Stand 5B16. •


Licensing Firm DevelopingProducts For New Cures

Italian-based Indena, a global leader in the identification, development, andproduction of active principles derived from plants, besides its production activity, iscontinuing its research and development of new products in oncological,cardiovascular, and neurological fields.

After licensing the new taxane IDN5109, Indena has identified a new molecule, adimer of thiocolchicine, IDN 5404, licensed to Abraxis BioScience. Preclinical data onthis molecule have been presented at the 100th Congress of the AACR (AmericanAssociation for Cancer Research).

Tests on various experimental models have shown that IDN 5404 is able to destroythe vascular system of tumors, a mechanism that is catalyzing the attention of the sci-entific community. The filing of the relevant Investigational New Drug application isforeseen before the end of 2009. Indena, besides having identified, developed, and li-censed the product, will perform submission of the DMF and the production of the API.

With reference to the neurological area, Indena is a leader in the production ofthe myorelaxant agent thiocolchicoside. In the frame of the research of newanalogues, a new molecule, IDN 5243, has been identified and developed and is nowthe object of an agreement with an important pharmaceutical company. Indena hasdeveloped this product until Phase I and is now implementing the clinical dataavailable, performing a repeated doses Phase I clinical study on healthy volunteers.

For the cardiovascular industry, Indena has patented a new combination ofextracts, Cholactiv, with a balanced composition that can simultaneously act on lipid,oxidant, and inflammatory profile, thus reducing the risk of cardiovascular diseases.Also this product has been licensed to a pharmaceutical company.

In addition to the above products, Indena is implementing its research activity,having in its pipeline original and patented products for new fields such as metabolicsyndrome and cognitive impairment.

Visit Indena at Stand 3D40, Hall 3. •

Newly WHO-GMP-Approved Plant ReadyFor Capseed Manufacturing

Nitika Chemicals’ new WHO-GMP-approved plant is ready for multi-particulate drug delivery systems(Pellets).

Capseeds (Pellets, Non Pareil seeds,Sugar Spheres, MCCP pellet, or excipientspellets) are approximately sphericalgranules of a nominal size range with auniform diameter. These are made fromvarious excipients systems, such as sugar,starch, MCCP, Mannitol, Lactose, dextrose,Magnesium Oxide/hydroxide/carbonate,and calcium carbonate. They areexcellent inert carriers for ActivePharmaceuticals Ingredients (APIs).

Capseeds (Pellets) offer a tailor-made drug delivery system ensuring stableformulations and uniform drug content. Specifically recommended for controlledand sustained release systems, multiple drug formulations involving incompatibilityissues, and sensitive drugs.

Capseeds (Pellets) are available with DMF, excellent spherical shape, low friabilityin FBP, small sizes from 100µ, and in various sizes, including 18-20, 20-25, 25-30, 30-35,35-40, 40-50, and 50-60.

Capseeds are also available in different grades:• CAPSEEDS FBP—With low friability, suitable for fluidized bed processor• CAPSEEDS CP—Suitable for processing in coating pan & centrifugal granulator

Customized Density• CAPSEEDS—Desired density to reduce segregation during processing• Customized composition CAPSEEDS—Tailor-made using different excipients

system• Microcrystalline Cellulose CAPSEEDS—Made up of microcrystalline cellulose

powder (MCCP)• Sugar Spheres USP/NF/EP—Made as per USP/NF/EP monographs• Sugar Globules—Specially made Sugar Pellets

Visit Nitika Chemicals at Stand 6G24. •

Oncology Parenterals Formulation For Clinical Needs

MP5 is the contract manufacturing organization that specializes in the formulationand fill/finish of targeted parenteral cytotoxic/cytostatic therapies for small Phase 1and 2 oncology clinical trials.

Its 12 years of experience have provided it with a proven track record informulation and fill/finish parenteral cytotoxic therapies for oncology clinical trials.With more than 279 batches, the track record of experience spans non B-lactimantibiotics, enzyme inhibitors, non-biologic cytotoxics, peptides, and proteins.

Its dedication to developing solutions for small Phase 1 and 2 oncology clinicaltrials enable highly efficient processes and quick product delivery. The GMP facility is

designed to be modular and adaptable to meet a project’s specific needs. The GMP facilities are fully US FDA, EMEA, and AFSSAPS compliant. With

documented quality processes that focus on continuous improvement, the facilityoperates under isolators for total compound containment for the protection of theoperators and environment. Priority is given to cross contamination minimization.Among the safeguards:• Dedicated and single use equipment and glass vessels• Peristaltic pump with single use tubing for filling• Single use isolator gloves and HEPA filters for each campaign• Production within isolations for total compound containment• Specific cleaning and cleaning testing methods for each API based on the specific

compound

As a partner in small Phase 1 and 2 high potency cytotoxic parenteral projects, MP5provides not only fill and finish but formulation, but CMC support andtroubleshooting capabilities. Its unique capabilities include the development andoptimization of processes for liquid and lyophilized formulations.

Analytical laboratory services include method development and validation, pre-stability, and stability testing.

Strong project management processes and an experienced staff are able todeliver a product on time to meet clinical trial start dates.

In addition, clinical supply needs (labeling, packaging, cold chain, and distributionto clinical sites) can be fulfilled by MP5’s sister company, Creapharm, a leader ofclinical trial supply services in France and Europe.

Visit MP5 at Stand 8 BIO 22. •


NiKem Offers MALDI ToF/ToF Imaging By Mass Spectrometry

Matrix-assisted laser desorp-tion/ionization MALDI has tradi-tionally been used for peptidesand proteins, but in the late1990s introduction of MALDIToF/ToF and MALDI/Q-ToF ex-panded the scope of the tech-

nique to the analysis of low molecular weight, molecules. Improvement of the lasertechnology has allowed scanning of tissue slices to which an appropriate matrix hasbeen applied down to 50um resolution to give a visualization of tissue distribution ofthe target molecules. Scanning multiple slices from a tissue allows the rapid generationof a 3D-distribution map for target compounds.

Imaging by mass spectrometry has major advantages over whole bodyautoradiography. With no radio label required, significant amounts of time andmoney is saved. Not only can a parent compound be analyzed, its metabolites andany relevant biomarkers can be simultaneously mapped.

This is a valuable research tool for the identification of compounds giving therequired target organ distribution and to understand PK/PD relationships. While inprincipal any tissue can be analysed, the key consideration is always how well thetarget molecule ionizes from the selected tissue.

The output from the technique is provided as a “heat map” of the relativeconcentrations of drug across the tissue as shown by the distribution map ofmidazolam in the mouse brain generated by NiKem Research.

NiKem Research is now offering imaging by mass spectrometry as a service tosupport research programs using the Bruker Autoflex III. Examples of tissuesinvestigated by MALDI/ToF/ToF by NiKem include bladder, liver, brain, and tumours.

Initial check for efficient ionization of the target compound from the requiredtissue is provided free of charge by NiKem Research.

For more information please see www.nikemresearch.com or [email protected] T: +39 02 356941; F: +39 02 356947606. Visit NiKem atStand 8NE01. •

Controlled Drug Substance ManufacturerFeatures Multiple Capabilities

Rhodes Technologies, a young and fast growing APImanufacturer located in the heart of the U.S. northeastpharmaceutical corridor, has a core business withconcentration on controlled drug substances (CI-V),including opiates and cannabinoids. It is one of theworld largest manufacturers of oxycodone.

With its multi-purpose, FDA-registered, and DEAcertified plant, it offers a range of active

pharmaceutical ingredient production capabilities, including process development,synthesis, preparative chromatography, drying, plus advanced micronization suiteswith state-of-the-art jet mills, as well as dosage form manufacturing suits.

As an independent firm associated with a worldwide group of privately heldpharmaceutical companies, Rhodes is staffed with a broad spectrum of professionaltalent, drawn from both pharmaceutical and chemical operations. They combineknowledge of chemistry and materials science with an understanding of regulatoryrequirements in large scale manufacturing of APIs in a cGMP environment.

An active participant in the SOCMA Responsible Care Management System (RCMS)program, Rhodes has broad capabilities in developing sophisticated chemicals andoffers confidential production of high purity APIs for innovative pharmaceuticals.

Visit Rhodes Technologies at Stand USP049 (US Pavilion Hall 4). •

New Pharma Products Under DevelopmentDexa Laboratories of Biomolecular Sciences, a member of Dexa Medica Group anda leading pharmaceutical company in Indonesia, has committed to develop newpharmaceutical, biopharmaceutical, and nutritional products. DLBS uses aproprietary system to screen candidate natural products into medicinals. Currently,DLBS is ready to offer multiple products that have been proven clinically.

Visit Dexa Labroatories of Biomolecular Sciences at Stand 8H07.


Manufacturer Adding AdditionalServices for Tablet Formulation Melbourn Scientific is now offering new services for tablet formulation, particlecharacterization, and nebulizer development. Additionally, the company hassuccessfully passed an FDA audit, despite being in the middle of a major expansionprogram that is doubling its available lab space and creating dedicated new areasfor its formulation team and other specialist services.

Mark Hammond, CEO, said that the positive FDA audit follows a successful UKMHRA GMP (Good Manufacturing Practices) inspection a few weeks ago. “One of thekey drivers for us as a business is a policy of continuous improvement in all areas andthis has been reflected by the successful completion of these two audits,” Hammondsaid. “Our investment program includes increasing capacity for our AcceleratedFeasibility Studies. With the economic events of 2009 and the effects this has had onthe pharmaceutical industry, we have seen increased pressure on project timelines.As a result, our clients need more information faster than ever before, and webelieve our AFS offer significant advantages.”

Running a series of pre-formulation, analytical, stability, and formulation studiesin parallel offers an effective way of managing time critical projects. For example, byusing a matrix of tests to ensure that the key properties of a compound are welldefined, the company can tailor an effective formulation to optimize delivery andstability of the final drug. Done well, this process can add value to projects by helpingto inform design decisions and avoid expensive mistakes later in the process.

Demand for these types of studies can be seen as an indication of productpipelines refilling. In addition, new delivery systems or dosage forms for existingdrugs have also driven a need for specialist stability testing, all of which indicatesrising levels of activity in the industry. Melbourn Scientific provides high qualityanalytical and formulation services to the pharmaceutical and healthcare industry.Clients include major pharmaceutical companies, drug delivery innovators,consultants, and virtual companies. Melbourn Scientific has invested continually inthe latest equipment and provides a range of services: pharmaceutical analysis,physical testing, stability trials, HPLC, and inhaled product analysis.

Visit Melbourn Scientific at Stand 8A54. •

Clinical Trial of SR Exenatide Cruising AheadPeptron, a peptide SR drugdevelopment company, reportsthat the clinical study toevaluate the safety as well asPK/PD of SR exenatide is goingwell. Exenatide is a 39-aminoacids-long peptide used for thetreatment of type 2 diabetesmellitus. Exenatide is a GLP-1analogue that facilitatesinsulin secretion with the side

effect of body weight loss, and is considered to become an alternative to insulin intreating diabetes patients in the future.

Peptron had previous success in developing one- and three-month leuprolide andone-month octreotide SR injectable products. The products are either approved ormarketed or in clinical trials.

Heeyong Lee, director of DDS research division of Peptron, said that the three SRpeptide products prove that Peptron is capable of developing SR products of peptideand even small-molecule drugs.

NeoPharm participated as the SR exenatide project financer; clinical samplesand commercial products are manufactured by Samyang Genex. The clinical trial hasbeen conducted by the Seoul National University Hospital.

Peptron is seeking pharmaceutical companies interested in co-development ofthe SR exenatide product, as well as sales and marketing partnerships in variousregions or countries.

Visit Peptron at Stand KP03. •


Czech Company Focuses on QualityCzech Republic-based Macco Organiques is a global leader in the production ofpharmaceutical calcium chloride and magnesium chloride. High quality has alwaysbeen the company’s priority. Its products and production processes reflect this ethosand are certificated to GMP (ICH Q7), ISO, CoS, HACCP, DMF, Halal, and Kosherqualifications. To further support production, the company offers other, mainlyinorganic salts for dialysis and infusions solutions, table water, for infant formulas,nutritional supplements, pharmaceuticals, and for veterinarian preparations.

Visit Macco Organiques at Stand 4A81, Hall 4. •

Metal Recovery Technology FuelsExpansion, Cost-Savings

Phosphonics reports that in 2009 it has expanded its Precious Metal Recoverytechnology by completing successful commercial scale projects for platinum,rhodium, palladium, and ruthenium recovery.

The Precious Metal Recovery product line has been developed out of PhosphonicsCPhI award-winning metal scavenging technology.

The technology is designed around a family of materials designed with highcapacity and selectivity for precious metals. This is combined with a variety ofapplication options and engineering solutions, linked to a normal metal refiningprocess loop. It allows an economic approach to recover metals such as palladium,ruthenium, rhodium, and platinum from waste and process streams that havepreviously been difficult to treat.

“With the pressure on costs and the sustained demand for precious metals, evenwith the recent price reductions we have seen a strong demand for these products,”commented Phosphonics CEO, David Astles. “Recovery of precious metals fromprocess and waste streams where the metal is present at low concentrations inorganic, aqueous, or mixed solvent systems is often difficult to achieve economicallyby other means.”

API Metal scavenging—Complementing the Precious Metal Recovery technology,Phosphonics’ functionalized silica materials for precious metal scavenging from APIsare now well established as a solution of choice because of their exceptional cost-performance, high purity levels, and the ready scalability of the technology.

A low-cost screening service is available or alternatively convenient test kits areprovided for clients to use in their own screens.

Organic impurity scavenging—Phosphonics‘ materials have also been developedfor use in organic scavenging applications at process scale. Traces of commonalkylating agents, as well as a variety of other common reagents and by-products(including phosphines, boronic acids, amino acids, and amines as examples) can beremoved. Visit Phosphonics at Stand 7F70. •


Partnership Creates One-Stop-Shop for PK Study

The collaboration between BioClin and Shandon provides generic and drug deliveryclients with integrated bioanalytical and clinical testing services for pilot pharmaco-kinetic and pivotal bioequivalence studies. The integrated program, Klinetics, offerscompanies the ability to conduct such work in Europe, facilitating rapid, cost-effec-tive, and efficient clinical pharmacology studies.

Klinetics combines BioClin’s clinical testing experience and Shandon’s expertise as aPhase 1 CRO to create an integrated bioanalytical and clinical testing service. Klineticsallows for the integration of study design, CTA submission, IMP import and QP release,clinical batch stability, clinical conduct, bioanalysis, pharmacokinetic, and statisticalanalyses and report generation to support regulatory submissions in the EU and U.S.

The introduction of Klinetics formalizes the collaborative approach to clinicalpharmacology studies that has been employed by Shandon and BioClin for a numberof years. For Phase 1 clinical studies, the partnership operates as a single CRO; byremaining separate companies they retain flexibility and avoid the bureaucracy oflarger organizations. Their clients find that this translates to increased speed atcompetitive prices. It is an ideal opportunity for companies wishing to access theregulatory benefits of conducting clinical pharmacology studies in Europe.

BioClin, part of the Intertek Pharmaceutical Services network, is Ireland’s leadingGLP-certified, FDA- and cGMP-compliant laboratory, providing pre-clinical and clinicalbioanalytical and cGMP pharmaceutical testing. BioClin has developed more than250 laboratory methods across toxicokinetic, first-in-man, dose escalation, proof ofconcept, invitro/invivo, and bioequivalence and bioavailability studies.

Cork-based Shandon, Ireland’s only independent Phase 1 clinical research center,performs between 25 and 30 Phase I clinical studies annually for a range ofpharmaceutical and generic drug companies. Shandon’s relatively small size allows it toapply rapid responsiveness, flexibility, and creative problem solving to contract clinicalresearch while maintaining the highest standards of good clinical practice (GCP). After 16years and with more than 300 pharmacokinetic studies completed, Shandon offers awealth of scientific experience. Visit BioClin at Stand 8BIO40, Hall 8. •

Cutting Edge R&DLaboratory OpensIn response to Interquim’s decision to expand its generics business, the R&D teamhas been enhanced by new highly qualified personnel and cutting-edgelaboratories, equipped with all the technology needed for the development,optimization, and scaling-up of chemical processes.

The R&D building is ecologically sustainable and features a 600 sq.m. specialroom for hydrogenation with a polyclave hydrogenator to carry out reactions at ahigh range of pressures and temperatures, a short path distillation plant KDL 5,scaling-up plant with a 20 L Büchi reactor, and laboratories with standard materialand instrumentation needed for the synthesis of any organic compound, including apreparative HPLC. All aspects of the new building are designed to offer the safestworking conditions possible. The building is completed by an extensive range offacilities, including a warehouse, library, meeting room, and offices

Interquim S.A was founded in 1978 as the API manufacturer for Ferrer Grupo. Fromthe beginning the R&D department has been crucial in developing the optimalmanufacturing processes.

Visit Interquim at Stand 7G12, Hall 7. •

API Manufacturer Enters Oncology Market

Having established a reputation as a leading Paclitaxel API manufacturer, SamyangGenex is expanding its business portfolio. The company added an injectablemanufacturing facility in 2007 and has developed and introduced several oncologyfinished products such as paclitaxel, docetaxel, oxaliplatin, and gemcitabineinjectables. Now, Samyang Genex, ready for customers that want to developadditional oncology products, has established joint-venture projects with Peptron forOctreotide and Exenatide in finished dosage form. Exenatide has been granted forclinical trial in Korea and is undergoing Phase I trial in Korea.

Samyang Genex is expecting to sell more than 100kg of Paclitaxel annually. Inaddition, the company reports that the manufacturing facility for Docetaxel will becompleted for a 2010 launch. Not far behind is the next generation of taxane-relatedAPI called Epothilone. Samyang Genex has developed its own high-yielding cell linefor producing Epothilone B and reports that the scale-up has been very successful.Vancomycin-HCl, an antibiotic API, has added another dimension to the company’sAPI lineup, and Samyang is expecting to sell more than 2 metric tons of the API in2009. Another added dimension to Samyang’s API business is Tacrolimus, animmunosuppressant that is already in business discussions with several majorcustomers from Japan.

Samyang Genex has passed the re-inspection from German Health Authority inlate 2008 for the renewal of its GMP certificate for another three years, and thus hasproven it’s the efficacy of its GMP system.

Visit Samyang Genex at Stand KP10, Hall 10. •

Supplier Celebrates 40-year Anniversary

Selectchemie, an independent Swiss distributor and sharing its booth 5A24 with oneof its premier principals ASAHI Kasei Chem, is celebrating “40 years added value” tothe supply chain of bulk raw materials.

Group companies are located in Brazil, France, and Italy. Prompt delivery of a widerange of ingredients are assured by Selectchemie’s logistical network andwarehouses.

Co-operations have long-term win-win situations for all involved parties.Commercial professionals, pharmacists, chemists, and food engineers with industrialexperience respond to countless questions raised by customers, as well asmanufacturers.

Visit Selectchemie at 5A24, Hall 5. •

MSN Gets CEP Approval for Moxifloxacin Hydro ChlorideMSN Laboratories, a leading manufacturer of APIs and formulations based in India,has been granted the first CEP in the world for Moxifloxacin Hydrochloride(Moxifloxacin HCL). With a total market size of more than $1.5 billion (USD),Moxifloxacin HCL is one of the leading quinolone anti-infective products on themarket. Moxifloxacin HCL is indicated for the treatment of respiratory infections,including acute sinusitis, acute exacerbations of chronic and community-acquiredpneumonia, as well as skin and skin structure infections. Moxifloxacin HCL is also soldin an ophthalmic solution (eye drops) for the treatment of conjunctivitis.

MSN Laboratories has 25 US/EU DMFs and four CEPs, with 13 DMFs and four CEPscurrently under review.

MSN Laboratories offers both the polymorphs (Anhydrous and monohydrate) ofMoxifloxacin for the generic formulation development. An international patent onthe improved process for the manufacturing Moxifloxacin HCL by MSN Laboratorieswas published in 2007. Visit MSN Laboratories at Stand 10D15. •


New Low-In-Endotoxins Products AvailableDr. Paul Lohmann is a leading provider of high-purity mineral salts to the pharmaceutical, nutrition, anddietary supplement industries. The company provides customers with a broad portfolio of mineral salts,with in excess of 350 products in more than 4,000 qualities, designed to provide optimum performanceacross a wide range of applications.

In the company’s GMP- and ISO 9001-certified facilities, it produces minerals that are in compliancewith the various regulatory requirements, current pharmacopoeias, and customers specifications. Tosupport customers in their registration efforts, Paul Lohmann prepares DMFs and has CEPs available for agrowing number of products.

The company has extended its product portfolio by introducing the low-in-endotoxins product range.These qualities are particularly relevant to the manufacture of liquid pharmaceutical products forinfusions or injections.

Dr. Paul Lohmann’s “minerals low in endotoxins” are produced on a new, dedicated production line.This enables the company to manufacture mineral salts, which achieve the stringent qualityrequirements necessary within the relevant industries.

Currently, 13 mineral salts based on calcium, magnesium, potassium, and sodium are available in alow-in-endotoxins quality. This product range is continuously expanded, and customer requestsconcerning individual product developments are welcome.

Other products offered by Dr. Paul Lohmann include granulated and direct compressible mineral salts.The advantages of this product line are:• Direct compression without wet granulation• Good flowability, compressibility, and disintegration factor • Manufacturing of tablets with fine-grain structure, optimized hardness, and smooth surface• These qualities enable customers to achieve cost savings in tabletting.

At present, 11 different mineral salts based on calcium, iron, and magnesium are available in a directcompression quality. Custom manufacturing of new DC-grade minerals is available per request.

Visit Dr. Paul Lohmann at Stand 5A15, Hall 5. •

New Platinum API PlantFully OperationalIn keeping with efforts to improve quality and market share,Umicore has constructeda new $8 million state-of-the-art Platinum API plant in Argentina. The plant becamefully operational earlier this year and makes use of the company’s unique metallurgyand chemistry expertise, to produce important Oncology Platinum APIs, including Cis-platin, Carboplatin, and Oxaliplatin.

The new APIs are manufactured according to the highest quality and socialstandards. The GMP-approved plant produces under the guidelines of USP, EP, and JPand is compliant with ISO 9001 and 14001, complying with the most stringentinternational standards. For the first time in its history, Umicore will offer its uniquecombined expertise on both APIs and precious metals to customers worldwide.

As the company’s Platinum API production is fully integrated into its closed-loopconcept, Umicore’s customers are assured of continuous platinum availability. The newfacility will significantly increase production capacity and provide Umicore with theflexibility to supply a large number of key Platinum Oncology customers on a globalscale. Umicore’s customers can count on the active support of the company’s dedi-cated marketing and sales teams in more than 50 locations worldwide.

By offering first-class products, Umicore is committed to become a market leaderfor Platinum APIs.

Umicore Precious Metals Chemistry is a leading manufacturer of highly pure andactive precious metals catalysts and chemicals for use in various industries. Besidesthe company’s range of inorganic chemicals, it has developed a wide range oforganometallic precious metal catalysts and precursors, which are used primarily forhomogeneous catalysis applications.

With more than 40 years of experience in precious metals chemistry and morethan a decade of Platinum API experience, Umicore is a globally recognized partner.

Visit Umicore at Stand D50, Hall 3. •

New DIOLS Lines OfferedSabinsa Europe is offering an expanded product line to address the entire range ofDIOLS need in tons. The new product line will include:• 1,2-Decanediol • 1,2-Hexanediol • 1,2-Dodecanediol • 1,2-Octanediol

With a distinguished background and a reputation for good quality, Sabinsa isexpecting to become the manufacturer of choice for DIOLS products. Unlike manycompetitors with whom clients must choose between getting a good price or gettingthe product quickly, Sabinsa provides customers with competitive pricing and shortlead times. Visit Sabinsa Europe at Stand H37, Hall 10. •


Ubichem UnveilsNew Website toUpdate Image

New Gel/Liquid Polymer IntroducedPolymerExpert’s patented technology ExpertGel is a uniquepolymer that forms thermoreversible hydrogels. At lowconcentration, ExpertGel behaves as a liquid at ambienttemperature and as a gel at body temperature, with the process completely reversible. The gelation temperature is easily and precisely adjustable between 25°Cto 45°C.

Once formed, hydrogels have several appealing properties,including: • Muco-adhesive, making them excellent candidates for

nasal, vaginal, or throat sprays as well as wound sealants.• Unaffected by pHs between 1 and 12.• Tolerant of a wide variety of formulation ingredients,

making them interesting smart excipient for variousgalenic compositions.

• Display delayed release characteristics and canencapsulate a large range of pharmaceutical activeingredients.

The release kinetics of ExpertGel formulations have beenstudied in aqueous water/water hydrogel form (eye drops andlotions), emulsions (creams), and solid form (tablet). Benefits ofExpertGel products have been demonstrated in such domainsas smart thickening agents, viscosity controllers, new texturingadditives, and injectable implants.

Visit PolymerExpert at Stand 8G11. •

Xcelris Offers Customized ContractManufacturing Services

Xcelris, a boutique contract research andservices organization, specializes in thedevelopment of speciality Cytotoxicinjectables, lyophilised products, andgeneral parenterals. From its state-of-the-art injectables development facility,Xcelris can undertake variations and hasaccess to USFDA- and MHRA-approvedmanufacturing. The company providesopportunities to global pharmaceuticalcompanies to make available theirmedicines globally at an affordable price.Visit Xcelris Labs at Stand 7G39. •

In keeping with its expansion over thepast year, Ubichem has unveiled anupdated corporate image and newwebsite designed to better reflect anddemonstrate the company’s forward-thinking and customer-orientatedethos.

Ubichem offers services for early-phase pharmaceutical developmentand fine chemical sourcing—and sodoes the new website, with easynavigation and added functionality tohelp users find what they need—be itsourcing material on a milligram to tonscale or expert drug developmentadvice and services. The website offerscustomers all of its existing services,plus an intuitive new search facility byCAS number or chemical structure.

Ubichem likes to go the extra milefor its clients. For instance, some finechemicals clients like to take advantageof bulk discounts, but don’t have thespace to store large quantities. Ubichemcan do that for them.

At CPhI 2009, visitors to Ubichem’sstand may try out the company’s newwebsite and consult experts on anyaspect of its out-sourcedpharmaceutical development servicesor fine chemicals sourcing.

Visit Ubichem at Stand 3G55, Hall 3 •


Formulation of High-Potency Drugs by Isolator Technology

Isolator technology ensures a manufacturing process thatprotects operators from product exposure and the productfrom human contamination. The process also guarantees amaximum sterility assurance level (SAL) in the asepticenvironment.

Biodecontamination of the environment inside the isolatoris obtained by Vaporized Hydrogen Peroxide (VHP) to achievesterilisation without harmful residues. Only a limited numberof plants the U.S. and Europe are able to offer thissophisticated technology. Pharmintraco is specialized inmanufacturing of parenteral formulations of high-potency APIsunder aseptic conditions, in liquid or lyophilized form.

Vials, varying from 8 to 100 ml capacity, are filled, starting

from a bulk solution of 20-500 L, thus satisfying demand forboth pilot and industrial batches.

The Pharmintraco site operates according to cGMP andSwiss environmental standards, which are recognized by theworld’s major regulatory authorities.

Visit Pharmintraco at Stand 7C71. •

Double Dose of Drug SafetyLimits Risks

Fake drugs expose patients and pharma-ceutical manufacturers to serious risks.The growing incidence of pharmaceuti-cal product piracy and drug tamperingin recent years has magnified the risks tohuman health as well as the business ofpharmaceutical manufacturers. Togetherwith the security experts from SchreinerProSecure, Schreiner MediPharm hasdeveloped an innovative syringe label aspart of its Pharma-Comb range to ad-dress this problem.

SecuMed2 provides particularly effec-tive protection against counterfeitingand tampering due to its multi-step sys-tem, consisting of overt and covert au-thenticity features. The interactionbetween them facilitates the authenti-cation of the product by the patient,physician or pharmacist. SecuMed2 pro-tects the health of patients—and phar-maceutical manufacturers from damageto their image as well as unjustifiedproduct liability claims. This protectionhas long-term value: SecuMed2 has twodetachable documentation labels withauthenticity features. These can be ap-plied to the patient’s medical records toprovide permanent proof of the authen-ticity and origin of the drug which hasbeen adminstered to the patient.

Visit Schreiner MediPharm at Stand8G70. •

Manufacturer Produces Pharma Ingredients

Moehs, a fine chemical company, produces active pharmaceu-tical ingredients and custom synthesis, as well as some inter-mediates. Visit Moehs at PMC Europe at Stand 3D51. •

Supplier IncreasesProduction CapacityNanjing Lanya Chemical supplies TriethylSilane, Triethyl Chloro Silane, Acetyl Ace-tone, Montelukast Sodium Intermediates,Atracurium Besylate and its intermedi-ates, and Pemetrexed Disodium and itsintermediates. For the increasing demandon Roche Tamiflu, Nanjing is increasingproduction of such products as TriethylSilane, as the raw material for that prod-uct, is also in tight supply. The company’sproduction capacity has been enlarged to15Mt/Month. Visit Nanjing Lanya Chemi-cal at Stand CA10053, Hall 10. •


Innovative SupercriticalSolutions for Drug Formulation

SuperCritical Fluids Research & Development Center is a recently established unit ofPierre Fabre Médicament, the second independent pharmaceutical Frenchlaboratory. The company’s new department has secured extensive expertise inSuperCritical Fluids, with a focus on the development of innovative API formulations.

Pierre Fabre’s main patented technologies are performed in a multi-purposeplatform in compliance with cGMP, (recognized as Pharmaceutical Establishment byFrench Health Authorities). These include, Formuplex, Formuldisp, Formulcoat, andmicro-nano particles processes used to improve bioavailability, solubility, or for taste-masking and particle design.

Other application areas available are: extraction, fractionation/enrichment ofnatural substances, purification, and cleaning/treatment of medical devices.Additionally, the company has a dedicated handling zone for high-potency APIs(cytotoxics).

Pierre Fabre is seeking external partners—from start-up to multinational—in themedical or paramedical field and from the early stage of development tocommercial scale.

Visit Pierre Fabre Medicament at Stand 6E28. •

Supplier Granted License forManufacturing Controlled SubstancesAesica Pharmaceuticals, a service-driven supplier of APIs, finished dosageforms, and custom synthesis solutions, has received license approval formanufacturing controlled substances.

Aesica's Cramlington, UK site has been recently granted a Home Office li-cense to allow manufacture and supply of substances listed in Schedule 2 of theMisuse of Drugs Act 1971. Granting of this license followed a program of invest-ment carried out to enhance the security of the site and its buildings, and theimplementation of special procedures for the handling of controlled substances.

These changes allow the Aesica Cramlington site to offer facilities forcontract manufacture of controlled active pharmaceutical ingredients inquantities from a few kilograms in its GMP pilot plant to tons in one of its bulkAPI plants. The first contract-manufactured controlled drug for one of Aesica’scustomers is already in production.

Aesica can now offer such controlled drug manufacturing capability at two sitesin the UK: Queenborough and Cramlington covering both active ingredient synthe-sis and manufacture and packaging of finished dosage pharmaceutical forms.

Visit Aesica Pharmaceuticals at Stand 4B29, Hall 4. •

Indian Biopharmaceutical ManufacturingFacility Under ConstructionIn collaboration with German-based Boehringer Ingelheim, Kemwell has begun theconstruction of a biopharmaceutical manufacturing plant in Bangalore, India.

With this collaboration, Kemwell will complement its early clinical supply services(ranging from full-service process development, manufacture, formulation, and filland finish) to become a one-stop-shop by accessing Boehringer’s cell linedevelopment and large-scale commercial production at facilities in Europe. “Mostimportantly, Kemwell and Boehringer Ingelheim will provide the customer with state-of-the-art technology from Europe along with the benefit of low cost manufacturingfrom India,” said Anurag Bagaria, VP of Kemwell.

The new greenfield state-of-the-art facility will be designed for processdevelopment, fermentation, purification, and formulation of biologics for early-phase preclinical and clinical studies. It will house a cGMP drug substancemanufacturing facility and a sterile fill and finish facility for drug product with a floorfor process development laboratories to support production of protein therapeuticsfrom mammalian-cell culture or microbial fermentation.

Through its partnership with Kemwell Biologics, Boehringer Ingelheim expects tostrengthen its presence for biologic services in Asia, providing state-of-the-art tech-nologies for economic manufacturing of innovative, high quality biopharmaceuticals.

Visit Kemwell in Stand 8C80. •

Terms & Conditions ReflectPatent Compliance TrendsAs announced last year, UBM has introduced revised Terms & Conditions for exhibitors across its global portfolio of CPhI, ICSE, BioPh, and P-MEC events. These reflect UBM’s alignment with the industry-wide coalition to raise pharma ingredients quality, compliance standards, and IP observance.

“We want to guide and assist exhibitors in managing the recognisedcomplexities of IP issues and third party rights,” commented CPhI eventdirector Annemieke Timmers.

Accordingly, UBM stresses to all exhibitors their need to verify—throughappropriate legal advice if necessary—their specific entitlement to displaygoods in the country hosting an event.

“We take world-wide trends in protecting patents very seriously. UBM,therefore, supports all appropriate industry efforts to maximize productcertification, regulatory, and IP compliance and enforcement—which are, inturn, key to the integrity of our event brands,” said Timmers.

She added: “Registered ownership or approved licensee status of IP mustbe clear and conform with the relevant laws of the country where our event isbeing held. Additionally, exhibitors need to keep in mind that even if they didnot make or own goods, they may still be legally responsible for their import,display, and promotion.”

UBM International Media’s General Conditions covering goods displayspecifically exclude: “…any counterfeit goods…or goods that infringe any thirdparty’s intellectual property rights.” Also excluded are any goods “prohibitedor restricted by local laws or regulations where the exhibition takes place.”

Under its General Conditions, UBM International Media reserves the optionto remove displayed goods that the company or relevant authority—such as agovernment agency or inspector—deem to be in breach of relevant IP rightsor which are prohibited or restricted under the hosting country’s national orlocal laws.

“Responsible and ethical trading is vital for the industry,” said Timmers.“While UBM has no regulatory function, we know that our exhibitors andvisitors expect the re-assurance that comes from taking a very clear positionand response if exhibits raise IP or compliance issues.” •


Nickel EnCat Marks Investment MilestoneReaxa, a pharma metal extraction technology leader, has announced furtherinvestment to support development of its Nickel EnCat immobilized catalyst, andformation of a new subsidiary, Reaxa India.

Nickel EnCat is now in trials at a major pharma player in preparation for bulkscale production of a high-volume API. Multiple-use Nickel EnCat catalyst deliversmajor gains in API process yield, reduced contamination levels, and greater costeffectiveness, compared with the standard Raney-type nickel catalysts.

This product is an immobilized nickel catalyst that traps catalyst species in a porouspolymer bead, preventing product and waste stream contamination. EnCat technologycan be safer, simpler, and cleaner than processes using Raney/sponge nickel products—with re-use in multiple batches, driving down cost and metal consumption.

New funds will also be used to launch a new subsidiary, Reaxa India, to managesupply chain and commercial scale production, application development, and

marketing activities in India—and to further develop the Asian market.To support growth and large scale EnCat production, UK investors Enterprise

Ventures (EV) and YFM Private Equity are leading further investment.Also investing is India’s S. Amit, India’s leading full service chemistry solutions provider

and supplier of intermediates, and speciality & performance chemicals servicing thepharma, agrochemical, paints and coatings, and polymer additives industries in India.

Mumbai-based S. Amit is already the sales agent for Reaxa’s EnCat andQuadraPure ranges and will spearhead planned commercial scale manufacturingfacilities for Nickel EnCat under the Reaxa India banner.

Nickel EnCat offers an exciting alternative for up to 20% of the pharmahydrogenation catalyst market. Reaxa’s 27-product range includes the EnCat familyof 10 polymer-encapsulated catalysts and 17 QuadraPure and QuadraSil scavengingresins. Visit Reaxa at Stand 7F71. •

New Horizontal CasePacker Introduced

MG2, specialists for more than 40 yearsin the design and manufacture of auto-matic dosing and packaging machinesfor pharmaceutical and cosmetic prod-ucts, has recently launched GSL10, ahorizontal case packer.

The GSL10 horizontal case packeruses servo-motors for the main machinemovements and pneumatics only for thesecondary movements, thus combiningthe more advanced technology tosimplicity of utilization.

GSL10 guarantees:• Positive and forced case opening to

enable running even scarse qualitycardboard cases

• Reliability in product feeding andcollation

• Ergonomic design for operatorsafeguard

• Fast and easy size change-over• Case closure by either hot-melt glue

or tape• Possibility of placing the product in-

feed at the right-hand side of thecase magazine to better comply withuser’s production room

• Optional units such as: P&A labellers,pre-printed label dispensers, barcode readers, and ink jet printers canbe offered on request.

Output: up to 10 cases/minute,depending on the case size and productarrangement.

Visit MG2 at Stand 8E28, Hall 8.

Highlights from the Show Floor

Wednesday 14 October 2009

Strong Second Year for South America ExhibitionsHeld in the heart of Brazil’s pharmaceutical industry, São Paulo, late August’s CPhISouth America and P-MEC South America pharma ingredients and productiontechnology events built strongly on their 2008 debuts.

At just over 4,900, visitor numbers for the more than 150 exhibitors at theTransamérica Expo Center were almost 10% ahead of the 2008 launch event in Rio,with a major international presence. More than 70% of space for the 2010 eventshas already been sold.

Eliane van Doorn, UBM International Media’s Pharma Portfolio group director,commented: “Against the challenging business background since their launch lastyear, the 2009 events clearly delivered for both exhibitors and visitors, laying deepfoundations for next year.”

Alongside the exhibitions, the wide-ranging conference program included theISPE Brazil Life Sciences Congress; the 1st CRF-SP Clinical Research Seminar; the 2ndLatin American Pharma Business Forum; the 1st Sindusfarma Symposium of Pharma-ceutical Management and the BioPh-Biosolutions for Pharma conference on TheBrazil Regulatory Scenario.

Returning after the 2008 debut in Rio, the buyers’ and sellers’ “Match and Meet”networking sessions—on pharmaceutical ingredients, contract services, andlicensing—underlined the networking depth of the event.

Key Brazilian pharma trade organizations supporting the 2009 exhibitionsincluded ABIQUIF, ABRIFAR ABIMIP, ABIFINA, Alanac, ANVISA, ASSOCIQUIM, CRF-SP,Interfarma, Pró-Genéricos, and Sindusfarma.

“The good feedback on the quality of visitors and business networking valueclearly reflects the perceived importance of the event,” van Doorn said. “Withcontinuing market growth across South and Latin America, and the quickening pace of international partnerships as the standout themes, we are very positive for 2010.”

For 2010, CPhI South America and P-MEC South America move to Argentina’s LaRural, Hall Ocre facility in Buenos Aires, on Aug. 17–19. Next year will also mark the fulldebuts of ICSE South America and BioPh South America. In 2011, the fourth edition ofthe events will return to São Paulo. •


Informex Launches in Latin America in 2010Informex launches its inaugural Latin American chemical educational andnetworking event on Aug. 23–24, 2010 in, São Paulo, Brazil. The event will create anopportunity for professionals in the chemical solutions and innovations industry fromall over the world to meet in a single location.

This educational and networking event scheduled at São Paulo’s AmchamConvention Center will include an international congress and tabletop exhibition–uniting more than 1500 professionals, including exhibitors, visitors and congressparticipants.

With Latin America experiencing its longest period of sustained growth in morethan a generation, the industrial/specialty chemical products sector continues to seesignificant growth despite the economic downturn. In Brazil, the chemical industry’snet sales in 2008 exceeded US $120 billion: 50% of which represented industrialchemicals and 14% in pharmaceutical products, with remaining segments (paints,coatings, cosmetics, perfumes, crops/fertilizers) totaling 36%.

Specialty sectors—with select segments hosting pavilions to further highlightparticular products, ingredients and raw materials—include:• Agrochemicals—with a special “crop production” pavilion• Industrial Chemicals: adhesives, resins, electronics, fuels, lubricants, paints,

coatings, photographic, film, plastics, polymers, textiles, and water treatment• Consumer Chemicals: cosmetics, personal care, flavors, fragrances, food,

beverage, soaps and detergents

Informex Latin America will bring together purchasers and producers of fine,specialty and custom chemicals and technologies. Launching in Latin America l

provides opportunity for suppliers to showcase their products and solutions in agrowing region and be an invaluable opportunity to meet new clients.

For details on the event, visit http://www.informexlatam.com.br; for exhibitorinformation, contact Devin Hader, +1-609-759-4707 or [email protected]. •


Advertisers’ IndexCompany PageAesica Pharmaceuticals, Stand 4B29 . . . . 12Albemarle, Stand 3E48 . . . . . . . . . . . . . . . . . 19Almac, Stand 8D21 . . . . . . . . . . . . . . . . . . . . . 15AMRI, Stand USP106 . . . . . . . . . . . . . . . . . . . . . 1ARCH Pharma Labs Ltd.,Stand 53E8 . . . . . 36Ash Stevens, Stand NB40 . . . . . . . . . . . . . . . . 9Austin, Stand USP115. . . . . . . . . . . . . . . . . . . 28BioVectra, Stand USP051 . . . . . . . . . . . . . . . 28Beneo-Palatinit, Stand 7G10 . . . . . . . . . . . . 17Cambridge Major Laboratories,

Stand 10E59. . . . . . . . . . . . . . . . . . . . . . . . 13Changzhou Sunlight Medical Raw Material

Co., Ltd., Stand CA10030 . . . . . . . . . . . . . 31Clariant Specialty Fine Chemicals,

Stand 4B26 . . . . . . . . . . . . . . . . . . . . . . . . 14Codexis, Stand 5F24. . . . . . . . . . . . . . . . . . . . . 2Corning, Stand 8F32 . . . . . . . . . . . . . . . . . . . 23Dishman Europe, Stand 4G78 . . . . . . . . . . . 27Dottikon Exclusive Synthesis, Stand 6C22 16DSM Pharma, Stand 6D14 . . . . . . . . . . . . . . 41Excel Pharma, Stand 5C01. . . . . . . . . . . . . . 28Fabbrica Italiano Sintetici S.P.A.,

Stand 6C20 . . . . . . . . . . . . . . . . . . . . . . . . 30Guangzhou Hanfang Pharmaceuticals,

Stand CP6084 . . . . . . . . . . . . . . . . . . . . . 47Helsinn, Stand 6F24 . . . . . . . . . . . . . . . . . . . . 18

Company PageIsochem Groupe SNPE, Stand 5B12 . . . . . . 10Johnson Matthey Catalysts, Stand 3D52 . 47Jost Chemical Company, Stand 10B21. . . . 37Louston International, Stand 7G08 . . . . . 35PCAS, Stand 4F60 . . . . . . . . . . . . . . . . . . . . . . . 9Piramal Healthcare, Stand 5E06 . . . . . . . . . 8Prosonix, Stand 4H09 . . . . . . . . . . . . . . . . . . 29Regis Technologies, Stand USP035 . . . . . . 47Reliable BioPharm, Stand USP036 . . . . . . 13Roquette Freres, Stand 6C14 . . . . . . . . 24–25SAFC, Stand 3B56 . . . . . . . . . . . . . . . . . . . . . 48Saniver Limited, Stand 7E60 . . . . . . . . . . . 33ScinoPharm Taiwan, Stand 4C42 . . . . . . . 40Shanghai Chemspec, Stand 10G48 . . . . . . 39Siegfried Ltd., Stand 4C24 . . . . . . . . . . . . . . 21Solvias AG, Stand 3C52 . . . . . . . . . . . . . . . . . 11Sumitomo Chemical Co., Ltd. , Stand 3A6419TCI Europe, Stand 7J22 . . . . . . . . . . . . . . . . . 16Tosoh, Stand 10G20 . . . . . . . . . . . . . . . . . . . . 14Umicore AG, Stand 3D50 . . . . . . . . . . . . . . . 30Vertellus Specialties, Stand 6A05 . . . . . . . 13Zhejiang Cheng Yi Pharmaceutical Co., Ltd.,

Stand 10J45 . . . . . . . . . . . . . . . . . . . . . . . . 31Zhejiang Hisoar Pharmaceutical Co., Ltd.,

Stand 5E23 . . . . . . . . . . . . . . . . . . . . . . . . 35

Leadership Through KnowledgeOYSTAR Hüttlin is a leadingcompany for processingequipment from laboratoryto production, includingfluid bed dryers,granulators, and coatersfor solid particles and high-shear mixer equipment. Thecompany’s main focus is

solid dosage forms for the pharmaceutical industry and special applications for thechemical and food industry. Worldwide support is provided by OYSTAR Sales andService Centers in the U.S., Russia, China, and global trading partners.

OYSTAR Hüttlin has all the prerequisites for a pharmaceutical environment. ThePharma Center in Schopfheim is the site’s heart and covers an area of 600 squaremeters with complex features in clean rooms to meet l GMP hygiene requirements.Solid dosage production steps can be demonstrated under real conditions inaccordance to customer specifications.

To maintain a leadership position in the pharmaceutical industry requires thedesign of efficient and economic processes. For this reason OYSTAR Hüttlin issupporting customers with a multi-disciplinary know-how transfer in a team orindividual company approach. Using the synergy effects of the Pharma Center and theknow-how of OYSTAR Hüttlin, a series of seminars and tailored trainings are offered.Depending on the customer’s requirements, the main focus of such training sessionscan be on theoretical subjects or operator-based hands-on lectures. All aspects ofdevelopment and production of solid dosage forms will be highlighted from the basisof granulation via the experimental design to the compression of the tablets.

The “Expert of Solids” (four seminars, certificated by OYSTAR Hüttlin) is thepreliminary stage of the “Master of Solids” (additional two seminars, certificated byOYSTAR Hüttlin). Register now for the next seminars and get a 10% exhibitiondiscount.

Visit OYSTAR Hüttlin at Stand 8E22, Hall 8. •

Pressures Mount as Industry Urges Excipient Regs

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