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Podcasts

Webcast: Learn How to Avoid Risk Contamination in Your Sterile Cleanroom
June 8, 2011—Sponsored by Kimberly-Clark Professional

Webcast: Quality Control: Preventing Cross-Contamination in a Pharmaceutical Manufacturing Environment
June 21, 2011 (North America) and June 23, 2011 (Europe)—Sponsored by SGS

Webcast: Winning Regulatory Strategies and Opportunities in Dermatology
July 20, 2011—Sponsored by Dow Pharmaceutical Sciences

Podcast: A conversation with Jim Greenwood

Events

Lyophilization Technology - Practical Application of the Scientific Principles
June 13–June 15, 2011
Los Angeles, CA

Chemspec Europe 2011
June 15–June 16, 2011
Geneva, Switzerland

10th Annual Biological Production Forum 2011
June 20–June 22, 2011
Frankfurt, Germany

IVT’s 2nd Annual ACE
June 21–June 23, 2011
Philadelphia, PA

NC3Rs/Society of Biology Symposium
June 22, 2011
London, United Kingdom

PharmaBrand Summit 2011
June 27–June 29, 2011
Montreux, Switzerland

More events


FindPharma Search
June 2, 2011 PharmTech.com

News

FDA Unveils Inspections Database
FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010.
Click Here to Read More

Mylan Plans Direct Entry Into Indian Market
Mylan, a generic-drug manufacturer, announced that it will be rebranding its Hyderabad, India-based subsidiary, Matrix Laboratories, as Mylan. Click Here to Read More

Independent Expert Advises EMA on Benefit/Risk Communication
An independent report released by the European Medicines Agency highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines. Click Here to Read More

WHO Meets to Discuss Global Health Policy
During an eight-day series of meetings that concluded on May 24, 2011, the World Health Assembly passed 28 resolutions and adopted three decisions to guide the organization’s work and address global health issues. Click Here to Read More

Capgemini: Pharma Must Act Against Patient Noncompliance
The pharmaceutical industry has been called to action by a new report that highlights the health and cost repercussions of patient noncompliance. Click Here to Read More


Product Spotlight

Chromatography columns enable parallel screening

GE Healthcare’s PreDictor RoboColumn units are prepacked with the company’s BioProcess chromatography media to enable parallel, automated screening of media and conditions using a robotic system. The miniature chromatographic columns can perform various screening techniques, including ion-exchange chromatography, affinity chromatography, multimodal chromatography, and hydrophobic-interaction chromatography.

Operators can perform high-throughput process development (HTPD) by using the PreDictor RoboColumns with a robotic liquid-handling workstation, such as Freedom EVO from Tecan. This technique allows users to execute parallel chromatographic separations automatically. The columns’ miniature format also enables scientists to screen many conditions at the same time with low amounts of sample. The columns thus enable a technique that can improve companies’ process understanding. In addition, automation and parallel screening help minimize manual labor and reduce experimental time.

The PreDictor RoboColumn units can be run the same way that conventional columns are run. Operators can use the products to screen various parts of the chromatographic cycle, such as binding studies, elution studies, and wash studies. The PreDictor RoboColumns are designed to yield highly reproducible data that are similar to the results from conventional columns.

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Company Notes

The biopharmaceutical company Amarin has entered into several supply agreements regarding AMR101, a prescription-grade omega-3 fatty acid. Equateq and Chemport, manufacturers of polyunsaturated fatty acids for pharmaceutical and nutraceutical products, have agreed to provide Amarin with the active pharmaceutical ingredient (API) for AMR101. Equateq and Chemport, as well as Amarin's current API supplier, are each executing phased capacity expansion plans to create sufficient capacity. These suppliers are self-funding the expansions plans with some contribution for Amarin. In return for certain exclusivity provisions and subject to product approval, Amarin is obligated to make minimum annual purchases from Equateq ranging from approximately $10 million to $20 million and has agreed to pay Equateq a development fee up to a maximum of $0.5 million and up to $5.0 million for purchasing initial raw materials to be credited against future API purchases. Amarin is obligated to make minimum annual purchases from Chemport ranging from approximately $7.5 million to $15 million. Concurrent with its agreement with Chemport for commercial supply, Amarin agreed to take a minority-share equity investment in Chemport of up to $3.3 million. Amrin is also further considering adding a fourth API supplier. Additionally, Catalent Pharma Solutions, a contract development and manufacturing organization, and Banner Pharmacaps Europe, a provider of gelatin-based drug delivery technologies, have agreed to provide softgel encapsulation services for AMR101.

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Eli Lilly commented on a ruling issued by the US District Court for the Southern District of California that granted a request by Amylin Pharmaceuticals for a temporary restraining order related to litigation involving the two companies’ diabetes collaboration agreement. “We are disappointed with the Court's decision to grant a temporary restraining order in this case,” said Robert A. Armitage, senior vice-president and general counsel for Lilly. “We have complied with our contractual obligations under our agreements with Amylin in a manner fully consistent with all applicable laws. We believe that Amylin's allegations against Lilly are entirely without merit and we fully expect to prevail in this litigation.”

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Johnson & Johnson reports that it is reviewing its growth strategies for its pharmaceutical business with leaders from the company’s executive committee and pharmaceuticals segment. The company’s four strategies to grow its pharmaceuticals business include: focusing on differentiated medicines by expanding in immunology, oncology, and vaccines; prioritizing investments in internal research and development (R&D), strategic licensing, partnerships and select acquisitions; strengthening its geographic presence and increasing investments in emerging markets as well as in certain developed markets, such as Japan; and investing in talent and organizational capabilities locally, regionally, and globally.

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Labtec GmbH, a transdermal drug-delivery developer, has opened a GMP manufacturing facility for transdermal patches and oral dispersible films in Hamburg, Germany. The facility was certified as GMP-compliant following a three-day inspection by Hamburg health authorities in March 2011. The facility provides industrial mass production and includes coating and drying lines with variable coating widths, as well as slitting machinery and converting and packaging equipment dedicated to transdermal drug-delivery systems and oral dispersible films.

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Pfizer has formed strategic partnerships with the contract research organizations Icon and Parexel International, both of which will serve as strategic providers of clinical-trial implementation services during a five-year period beginning in June 2011. The new partnerships will be fully implemented during an 18-to-24 month period.

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Canadian generic-drug company Pharmascience has opened new R&D and production facilities in Montreal. The company invested approximately $40 million in the expansion. Pharmascience also has acquired Aegera Therapeutics, a clinical-stage biopharmaceutical company. Financial terms were not disclosed.

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Radius Health, a developer of osteoporosis drug therapies, and 3M Drug Delivery Systems, a provider of inhalation and transdermal drug delivery technologies, have agreed to collaborate on the development of a transdermal delivery option for BA058, Radius’ parathyroid hormone-related protein analog, for the treatment of osteoporosis, now in Phase I clinical trials. The BA058 Microneedle Patch will use 3M’s microstructured transdermal-system microneedle technology to administer BA058 through the skin as an alternative to subcutaneous injection.

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Schott, a provider of specialty materials and pharmaceutical packaging, has opened a primary pharmaceutical packaging facility in Zavolzhe, Russia. The new production site will initially employ approximately 60 employees and will produce ampuls and vials.

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SGS, a contract analytical and testing firm, has announced its plan to open a second life-science services facility in Mumbai, India. The new 15,000-ft2 facility will provide analytical development and quality-control testing services and is scheduled to become fully operational by mid-2012.

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Sigma-Aldrich has acquired all outstanding shares of Vetec Quimica Fina, a Brazilian manufacturing and laboratory chemical supplier, to expand its presence in Latin America.

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Valeant Pharmaceuticals International a specialty pharmaceutical company, has agreed to acquire Sanitas Group, a specialty pharmaceutical company with products in Central and Eastern Europe, for approximately EUR 314 million ($452.1 million). The deal is subject to customary closing conditions and regulatory approval and is expected to close in the fourth quarter of 2011.

Watson Pharmaceuticals, a generic-drug company, has acquired the Greek generic-drug company Specifar Pharmaceuticals for EUR 400 million ($575.3 million). Under the terms of the agreement, Specifar's former owners could also receive additional consideration based upon future profits of esomeprazole tablets during its first five years of sales, up to a maximum of EUR 40 million ($57.5 million). Specifar manufactures generic pharmaceutical products in a facility located in Athens with capacity for approximately 1 billion doses annually. A new facility is currently under construction outside of Athens. This facility will provide capacity to manufacture an additional 3 to 5 billion. EU certification of the new facility is expected in mid-2012. This capacity will permit Watson to convert additional third-party manufactured products to own-manufactured products. The transaction was signed and closed simultaneously and announced on May 25, 2011.

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected]

People Notes

The biopharmaceutical developer Geron has made several senior management appointments. Stephen Kelsey, PhD, has been named executive vice-president, head of R&D, and chief medical officer; Jane Lebkowski, PhD, has been appointed as senior vice-president and chief scientific officer; and Melissa Kelly Behrs has been named senior vice-president of strategic portfolio management.

Christian Holtmann has been named as CEO of Klöckner Pentaplast Group, a producer of pharmaceutical films, effective June 1, 2011, succeeding Tom Goeke who will continue as an advisor to the company. Holtmann most recently served as CEO of PolymerLatex.

PharmTech, the magazine
Current Issue cover
Gelatin Capsule Shell Cross-Linking
By Xiling Song, Yong Cui, Minli Xie
The authors develop a pratical approach to avoid unwanted interactions between pepsin and SLS in dissolution Tier II tests.
Click Here to Read More

Coming soon: The June issue features a report n high-potency and high-containment manufacturing.

 

 
 

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