Manufacturing

Indianapolis, IN (Jan. 11)-Eli Lilly and Company announced several strategic changes to its global manufacturing operations. The changes include termination of construction of a planned insulin manufacturing plant in Virginia, staff reductions in its operations for small-molecule active pharmaceutical ingredients (APIs), and investments in manufacturing biotech-based drug products

Brussels, Belgium (Jan. 11)-EPCglobal, the not-for-profit organization dedicated to driving global adoption of the Electronic Product Code (EPC), has ratified the electronic pedigree document specification.

Washington, DC (Dec. 28)-The US Department of Homeland Security (DHS) has proposed regulations for improving security at high-risk chemical facilities, a category that may include some pharmaceutical production facilities.

Darmstadt Germany (Jan. 8)-Merck KGaA closed on its roughly CHF 16.6 billion ($13.3 billion) deal to acquire a majority stake in the European biotechnology company Serono (Geneva, Switzerland), officially launched Merck Serono SA as a new entity within Merck KGaA, outlined its integration strategy, and announced plans to divest its generics business.

Berlin and Leverkusen, Germany (Dec. 29)? Bayer Schering Pharma AG was officially launched as a new company following the acquisition of Schering AG (Berlin, Germany) by the Bayer Group (Leverkusen, Germany).

Stockholm, Sweden (Dec. 15)-As part of a plan to expand its biotechnology production capacity, Pfizer, Inc. commissioned the construction company Skanska AB to build a plant in Strangnas, Sweden for manufacturing Pfizer's human growth hormone product "Genotropin" (somatropin [rDNA origin] for injection).

Hafnarfjordur, Iceland (Dec. 21)-The generic drug manufacturer Actavis Group is expanding its manufacturing capabilities in India and plans to close a facility in Norway.

Pore-size ratings are so unrelated to actual dimensions and so subject to anomalous interpretations as to make substantial dependency upon their values an unwise choice. Moreover, the means of measuring them are questionable. The pore-size rating system at best provides a qualitative differentiation.

Democrats are back on top in Congress and are mapping a broad agenda for change. Prescription drug pricing, medical product safety, and access to needed treatments are high on the priority list. Manufacturers will be in the hot seat answering questions about patent practices, high-risk products, and why drugs cost less in other countries than in the United States. The real challenge, however, will be to gain approval of a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) before the program expires on Sept. 30, 2007. Such legislation also would renew user fees for medical devices and continue the pediatric drug exclusivity program.

Industry will be challenged to embrace new methods of supply chain collaboration.

There are currently several hundred biotech-based drugs in clinical trials, representing around a quarter of all drugs in development - a proportion that looks set to increase.

In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.

Dec. 28, 2006 Company Notes: Albemarle, Clinical Data, Crucell, Merck, PDA, QLT, Sanofi Pasteur, Shimadzu

Pharmaceuticals current good manufacturing practice (CGMP) violations accounted for just 36 of the 441 Warning Letters issued by the US Food and Drug Administration in 2006.

US District Court for the Eastern District of New York Judge Joanna Seybert's Dec. 11, 2006 Order granting a preliminary injunction in RxUSA Wholesale, et al, v. FDA, barring FDA from enforcing some drug pedigree rules.

Astellas Pharma Inc. (Tokyo) will sell three European plants to the Temmler Group (Marburg, Germany), a pharmaceutical company and contract manufacturer. The move is part of Astellas's plan to reduce the number its production sites.

The US Food and Drug Administration has modified its requirements for drug pedigrees accompanying wholesale pharmaceutical transactions, following a US District Court preliminary injunction barring the agency from enforcing certain provisions of the rule that was to have gone into effect on Dec. 1.

Biotechnology stocks dropped 14% in 2006, giving up more than half of the value they'd picked up during a "stellar" 2005, according to G. Steven Burrill, CEO of Burrill & Company (www.burrillandco.com), the venture and merhant banking company. "Overall, it wasn't a great year for biotech," said Burrill in a year-end analysis, indicating that the biotechnology industry will finish the year with its collective market capitalization essentially unchanged, at approximately $490 billion. As for the future, biotechnology will continue to fuel a the transformation in healthcare, a tansformation emphasizing earlier disease detection, more targeted treatments, and adjunctive support through enhanced nutrition. We will see further progress on the personalized, predictive, preventative front...with new products targeting the "individualization" of medicine in the marketplace. Other predictions for 2007 include...

Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.

Basel, Switzerland (Dec. 5)-Lonza Group Ltd. and Singapore?s Bio*One Capital have formed a joint venture, Lonza Biologics Tuas, to build a large-scale mammalian cell-culture facility in Singapore for as much as $350 million.

Bothell, WA (December 12)?If the shareholders of biotechnology company Icos Corp. approve a proposed buyout by Eli Lilly and Co., all of Icos?s 700 employees will lose their jobs.

Princeton, NJ (Nov. 30)-Rockwood Holdings, Inc. agreed to sell its Group Novasep subsidiary for EUR 425 million ($567 million) to a consortium of buyers consisting of Glide Buyout Partners BV, Banexi Capital, and Group Novasep management.

Whitehouse Station, NJ, (Dec. 6)-Merck & Co., Inc. expects the initial phase of its cost-reduction program, first announced in 2005, to yield cumulative pretax savings of $4.5?5.0 billion from 2006 through 2010, with roughly $2 billion of that coming from implementing its manufacturing supply strategy.

Dublin, OH (Nov. 30)-Cardinal Health has announced plans to divest its Pharmaceutical Technologies and Services (PTS) segment, "a business that manufactures or packages 100 billion doses of medication every year for pharmaceutical and biotech firms, employs approximately 10,000 at more than 30 facilities worldwide and generates $1.8 billion in revenue," according to a company statement.

London (Dec. 8)-GlaxoSmithKline PLC agreed to acquire Domantis Ltd., a developer of antibodies for £230 million ($454 million) in cash.

This article describes the design and development of a material-sparing fluidization segregation tester for use with pharmaceutical powders. This tester offers several improvements over the current ASTM standardized test practice. Less than 20 mL of material is required to characterize the fluidization segregation potential of a sample. Features of the tester include powder containment for potent compounds, in-process monitoring of the fluidization conditions, and sample retrieval without the need for subsampling or riffling for typical analyses.

Brand-name manufacturers seek to protect their products.

Why do the biotech ventures mange to have such promising drug candidates while pharmaceutical R&D is facing a drug deficit?

EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

Crucell announces acquisition of SBL Vaccin AB