News

Accurate characterization of active pharmaceutical ingredients (APIs) is a critical part of the drug development process. The approaches used to characterize APIs with respect to structure, identification of impurities, and the solid-state were discussed by Andrew C. Kolbert, manager, molecular structure and spectroscopy, Cardinal Health (Dublin, OH).

The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.

The US Department of Health and Human Services (HHS, Washington, DC) awarded biotech company Cangene (Winnipeg, MB, Canada) a $362-million Project Bioshield supply contract for 200,000 doses of botulinum toxin immune globulin (heptavalent botulism antitoxin).

The Parenteral Drug Association (PDA, Bethesda, MD) finished the second stage of GMP training for representatives from the Republic of Kazakhstan?s Ministry of Health.

Abemarle, Aceto, Nastech Pharmaceutical Company, Novartis, Novo Nordisk, PerkinElmer, Inc.

RNAi therapeutics company SR Pharma plc (London, UK) has developed a process that allows it proprietary liposomal-based siRNA formulations ?AtuRNAi? drugs to be stored at room temperature and reconstituted in one step.

Recombinomics (Pittsburgh, PA) is again urging the World Health Organization to fully release all H5N1 avian influenza sequences, claiming their release would improve the selection of vaccines by helping scientists to identify the origin of the isolates and predict sequence changes.

Degussa AG (D?sseldorf, Germany) and Lynchem Co., Ltd. (Dalian, Liaoning Province, China) signed a contract to establish a custom manufacturing joint venture.

Gilead Sciences, Inc. (Foster City, CA) signed a definitive agreement to acquire the Canadian subsidiary Raylo Chemicals and most of its assets from Degussa AG (D?sseldorf, Germany) for 115.2 million euros ($147 million).

Solutia Inc. (St. Louis, MO) announced that its subsidiary, Solutia Europe SA/NV (SESA), had reached a definitive agreement to sell its pharmaceutical services business, which comprises CarboGen AG and AMCIS AG. Under the terms of the agreement, Dishman Pharmaceuticals and Chemicals Ltd. (Ahmedabad, India) will purchase 100 percent of CarboGen and AMCIS stock and related assets for $74.5 million, subject to a working capital adjustment.

Noting several violations in current good manufacturing practice regulations, the US Food and Drug Administration has issued a Warning Letter to Wyeth Pharmaceuticals?s (Collegville, PA) manufacturing facility in Puerto Rico.

BASF, Bayer, NovaDel, Parexel, Schering

Sandoz (Holzkirchen, Germany), the generics arm of Novartis (Basel, Switzerland), received approval from the US Food and Drug Administration (Rockville, MD) for "Omnitrope" (somatropin [rDNA origin]), a follow-on version of a previously approved recombinant human growth hormone (rhGH) product.

Bristol-Myers Squibb Company (BMS, New York, NY) selected Devens, Massachusetts as the site for its new, large-scale, multiproduct bulk biologics facility.

China?s State Food and Drug Administration (SFDA, Beijing, China) issued a notice on May 18, 2006, requiring drug regulatory departments of provinces, autonomous regions, and municipalities to further strengthen the supervision and management of drug manufacturers.

The US Food and Drug Administration (Rockville, MD) is withdrawing seven guidance documents "because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative) .

Schering-Plough Corporation (Kenilworth, NJ) announced plans to phase out manufacturing operations at its Manati, Puerto Rico site, expecting to discontinue operations there by the end of 2006.

On May 26, AstraZeneca (Wilmington, DE) announced it would invest $100 million in research and development in China over the next three years.

I always suspected that our purchasing manager had agreed to this just to save money . . .

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

Pharmaceutical Science & Technology News

Does "personalized medicine" mean personalized treatment or personalized molecules, custom made for a patient's specific biology?

To fully optimize MS performance, corresponding enhancements are required in the other functional components of the integrated LC/MS platform.

This column provides a summary of the key trends that are occurring within pharma–biotech alliances, as well as looking at biotech–biotech. It will explore the changing balance of power in pharma and biotech deals, providing examples and insights into which areas alliances are becoming increasingly popular.

Xethanol Corporation's (New York, NY) subsidiary CoastalXethanol signed a letter of intent with Pfizer Inc. (New York, NY) to purchase Pfizer's pharmaceutical manufacturing complex in Augusta, Georgia.

Abraxis BioScience Inc., Bristol-Myers Squibb Company, Cambrex Corporation, Sigma-Aldrich Corporation, SkyePharma

Rutgers, the state university of New Jersey (New Brunswick, NJ), the New Jersey Institute of Technology (Newark, NJ), Purdue University (West Lafayette, IN), and the University of Puerto Rico (Mayag?ez, PR) won a $15-million, five-year grant from the National Science Foundation (Arlington, VA) to improve the manufacturing of pharmaceuticals, food, and agricultural products.

The CDER and CBER have released a new "Guidance for Industry: Q8 Pharmaceutical Development," outlining what drug manufacturers should include in the Pharmaceutical Development section of International Council on Harmonization (ICH) Common Technical Document (CTD) submissions.

Chemir Analytical Services (Maryland Heights, MO) acquired Gateway Chemical Technology, Inc., (St. Louis, MO), a provider of custom synthesis and process development services.

Spectrum Laboratory Products (Gardena, CA) recalled its active pharmaceutical ingredient, tacrolimus, after learning that some lots of the ingredient are subpotent. At least one injury has been reported.