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Podcasts

Webcast: Formulation Development Strategies
September 28, 2011—Sponsored by BASF

Webcast: Preventing Costly Out-of-Specification Investigations
September 20, 2011—Sponsored by Mettler-Toledo

Webcast: Winning Regulatory Strategies and Opportunities in Dermatology
On Demand—Sponsored by Dow Pharmaceutical Sciences

Webcast: Quality Control: Preventing Cross-Contamination in a Pharmaceutical Manufacturing Environment
On Demand—Sponsored by SGS

Podcast: Considerations in ophthalmic formulation development for various ocular diseases

Events

8th European Congress of Chemical Engineering
September 25, 2011–September 29, 2011
Berlin, Germany

Amorphous Pharmaceutical Materials 2011
September 26, 2011–September 28, 2011
Amsterdam, the Netherlands

Extractables and Leachables for Pharmaceutical Products 2011
September 27, 2011–September 28, 2011
Dublin, Ireland

BioPharma Istanbul 2011
September 29, 2011–September 30, 2011
Istanbul, Turkey

IVT's 17th Annual Validation Week
October 24, 2011–October 26, 2011
Philadelphia, Pennsylvania

4th West Coast Forum on Clinical Supply Chain Management
December 6, 2011–December 7, 2011
Burlingame, California

More events


FindPharma Search
September 22, 2011 PharmTech.com

News

White House Deficit Reduction Plan Targets Biologic Exclusivity Period
President Obama released his plan for deficit reduction on Sept. 19, 2011, and included in the 80-page report are several provisions that would affect US drug makers if enacted.
Click Here to Read More

Novartis Updates Long-Term Strategy
Novartis presented an update on its long-term strategy, performance, and growth outlook last week, which revealed that the company is on track to deliver the strategic priorities it had set out in 2010. Click Here to Read More

GE Healthcare to Invest $1 Billion in Oncology
GE Healthcare, the health business of General Electric, will dedicate $1 billion of its total R&D budget during the next five years to its technologies for manufacturing biopharmaceuticals and for cancer research. Part of the money will go toward expanding the company’s cancer-diagnostic and molecular-imaging capabilities, as well.
Click Here to Read More

GSK to Harness Formula 1 Technology
GlaxoSmithKline (GSK) is looking to racecar technology as it seeks to improve its manufacturing, R&D, and consumer-healthcare areas. The company has formed a long-term partnership with the UK-based McLaren Group, which is best known for its expertise in the Formula 1 motor sport.
Click Here to Read More

Pfizer Plans Manufacturing Investment in Ireland; Alkermes Secures Supply Pact
Pfizer plans to invest EUR 145 million ($200 million) in its Grange Castle biotech-manufacturing site. Meanwhile, completion of the merger between Alkermes, Inc. and Elan Drug Technologies was announced in a press release on Sept. 16, 2011, following the approval by Alkermes, Inc. shareholders on Sept. 8, 2011.
Click Here to Read More


Product Spotlight

Anion-exchange media offers high dynamic binding capacity

Bio-Rad’s Nuvia Q ultrahigh-capacity anion-exchange media has a dynamic binding capacity of about 170 mg/mL. The high dynamic binding capacity enables customers to process large volumes in a short time. The media also requires smaller columns for given steps, and thus less hardware, than other anion-exchange media do. The product’s good flow properties and fast mass-transfer kinetics enable users to run processes at rates of 150 to 600 cm/h without losing the high dynamic binding capacity and while maintaining low backpressure.

The Nuvia Q media is intended for intermediate or polishing steps and has strong selectivity for typical feedstream contaminants, such as host-cell protein and DNA. The media withstands alkaline reagents, such as sodium hydroxide, and can thus be reused many cycles after being subjected to clean-in-place protocols.

The media is also designed to provide high recovery, which, together with its long life cycle, help to reduce users’ costs. The Nuvia Q media requires less elution volume from the column for users to collect product. This characteristic eliminates the need to concentrate the product for the following purification step.

Company Notes

Berkshire Hathaway has completed the acquisition of the specialty-chemical company Lubrizol for $9.7 billion, including approximately $700 million in net debt. With the closing of this transaction, Lubrizol is now a wholly owned subsidiary of Berkshire Hathaway, and its international headquarters remain in Wickliffe, Ohio.

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Bristol-Myers Squibb (BMS) announced today that it has completed its previously announced acquisition of Amira Pharmaceuticals, a small-molecule pharmaceutical company. As a result of the transaction, Amira has become a wholly owned subsidiary of BMS.

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Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications. Spress®; Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction. PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required. Learn more.

The CDMO Catalent Pharma Solutions’ consumer health business has completed the first phase of a multimillion-dollar expansion of its facility in Aprilia, Italy. During the last 12 months, Catalent’s Aprilia site has been expanded to include a new gelatine-production area, and new encapsulation machinery has been added for the production of traditional gelatin and Vegicaps capsules. Catalent has also added processing equipment such as a new turbo emulsifier to replace open roll-milling equipment. Capacity within inspection and drying areas has been increased.

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Jubilant HollisterStier Contract Manufacturing has announced that its Montreal-based facility has entered into a four-year contract to manufacture an over-the-counter, prescription-strength, women’s health treatment product with the total revenue being over $70 million during that time period.

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Covance, one of the world's largest and most comprehensive drug development services companies, now offers a comprehensive and integrated set of CMC Pharmaceutical Development Services, including API development and supply, preformulation and formulation, analytical and stability, and regulatory documentation services. This offering is built on the combination of top-five pharma expertise, facilities, and decades of excellent client service record. Covance is committed to helping you reduce the time required to development milestones and improve your molecule hit rate. www.covance.com/cmcpds

The CMO Lonza and Pasteuria Bioscience have agreed to secure a process transfer and manufacturing plan to produce Pasteuria spores in Lonza’s biochemical plant in Kourim, Czech Republic. Lonza will initiate manufacture of Pasteuria spores, a biological nematicide, in its Kourim facility beginning in late 2011. The biological nematicide developed by Pasteuria Bioscience is based on the natural microbe, Pasteuria spp., found in soil and known to infect and kill harmful nematodes.

The CRO Pharmaron has formed a strategic partnership with Merck Serono, the biopharmaceutical division of Merck KGaA, providing that Pharmaron’s new campus in the Beijing Economic and Technological Development Area (BDA) will serve as home to Merck Serono’s China R&D laboratory. The focus of this laboratory will be clinical bioanalysis and biomarker characterization, allowing for the identification of gene mutations among the Chinese population, early detection of disease processes, and the development of personalized medicines for cancer and neurodegenerative diseases.

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Teva Pharmaceutical Industries has signed an investment agreement for the construction of a manufacturing facility in Russia. The plant, which will be located within the pharmaceutical cluster in Yaroslavl, will be built in various phases. The first phase, for the manufacture of oral dosage-form products, is scheduled for completion by 2014.

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In other news, Teva Pharmaceutical Industries has signed a collaboration option to license and share purchase agreements to invest in Cocrystal Discovery (CDI), a biopharmaceutical company. This investment will be used by CDI to continue its development program of antiviral drugs that target viral replication enzymes. Currently, CDI is using its technologies to develop oral, once-a-day, broad-spectrum antivirals for the treatment of hepatitis C, influenza and rhinovirus (common cold). Under the terms of the agreement, Teva will initially invest $7.5 million in CDI, and the company will develop for Teva an antiviral drug targeting the polymerase enzyme of the hepatitis C virus. Upon completion of the initial development plan, Teva will have the option to make additional investments under certain milestones. Teva will have the right to exclusively license the drug for further development and commercialization under agreed-upon commercial terms.

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Sierra’s Online Flowmeter Store: Fast. Easy. Spot On. Next Day.
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Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com

People Notes

The CRO PPD’s board of directors has named Raymond H. Hill as CEO and elected him to the board, both effective Sept. 16, 2011. Hill was previously president of IMS Consulting Group, part of IMS Health, a provider of data, market research and consulting services to clients in the pharmaceutical and healthcare industries.

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The Bill & Melinda Gates Foundation has appointed Trevor Mundel as president of the foundation’s Global Health Program. Mundel, who is currently global head of development for Novartis Pharma, will start work at the foundation on Dec. 1, 2011.

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PharmTech, the magazine
Current Issue cover
FDA Perspectives: Understanding Challenges to Quality by Design
By Helen N. Winkle, Moheb M. Nasr
Directors from FDA’s Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.
Click Here to Read More

Coming soon: Pharm Tech's October issue will contain a special feature on new applications for disposables.

A Push for Green Pharmaceutical Manufacturing Standards
By Patricia Van Arnum
Sweden's Medical Products Agency issues a report calling for strengthening environmental standards for pharmaceutical production within the European Union.Click Here to Read More
 

 

 

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Quality by Design and APIs
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