Manufacturing

There is currently no vaccination or cure for prion diseases and contamination of a parenteral or infusion pharmaceutical product could prove fatal.

With a finger on the pulse of an evolving market, the sales and marketing team can visually demonstrate trends and new market opportunities to the R&D team

Introducing lean manufacturing into the pharma sector.

Cardinal Health halted production, sales, repairs, and installations of its "Alaris Signature Edition Gold" infusion pump after the US Food and Drug Administration (Rockville, MD) seized approximately 1300 units last Friday. The seized infusion pumps (model numbers 7130, 7131, 7230, and 7231) have a "key bounce" defect that may cause overinfusion of medications by more than 10 times the intended infusion rate.

The generic drug company Mylan Laboratories, Inc. (Pittsburgh, PA) plans to acquire a controlling interest (71.5%) in the Indian pharmaceutical company Matrix Laboratories, Ltd (Hyderabad, India) for $736 million.

Merck KGaA (Darmstadt, Germany) plans to invest 190 million euros ($245 million) to build a biopharmaceutical plant in Darmstadt, Germany. Production is expected to begin in 2010.

Merck acquires Serono

Washington, DC (Aug. 14)?A new report issued by the Pharmaceutical Research and Manufacturers of America identifies 418 drugs and vaccines developed through biotechnology. All of the biotechnology medicines and vaccines are now in clinical trials or awaiting approval by the US Food and Drug Administration (Rockville, MD).

Teva Pharmaceutical Industries Ltd. announced that the company will cease production at its manufacturing facility in Cidra, Puerto Rico during the fourth quarter of 2006.

The International Organization for Standardization (ISO, www.iso.org) has formally issued and published standard ISO 4644-8:2006, Cleanrooms and associated controlled environments-Part 8: Classification of airborne molecular contamination. The document covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments in terms of airborne concentrations of specific chemical substances (individual, group, or category) and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.

ZymoGenetics (Seattle, WA) has sued Bristol-Myers Squibb (New York, NY) over alleged infringement of ZymoGentics's fusion-protein technology patents.

Akzo Nobel (Arnhem, Netherlands) is moving forward with plans to separate its pharmaceutical business into a separate company, Organon Biosciences

The Shenzhen government is planning to build a new national biopharmaceutical park in the Shenzhen Grand Industrial Zone.

Aegis Therapeutics (San Diego, CA) has launched a new formulation technology to increase the stability of proteins and peptides.

MSD Technology Singapore Pte Ltd., a wholly owned subsidiary of Merck & Co., Inc. (Whitehouse Station, NJ) dedicated an expansion of its production facilities in Singapore on July 28.

GlaxoSmithKline (London, England) has developed a vaccine against the H5N1 bird flu strain that, the company says, shows better immune response than other vaccines in development.

Disappointed in progress thus far, the US Food and Drug Administration wants pharmaceutical manufacturers to make a greater effort to combat counterfeit products and recommends that they "move quickly" to implement radio-frequency identification technology.

The new drug user-fee program will define how FDA does business over its next 100 years.

How does the latest agency task force report resonate for pharma and radio-frequency identification?

Genzyme Corporation (Cambridge, MA) reports the US Food and Drug Administration (Rockville, MD) has approved the fill?finishing, packaging, and labeling of "Thymoglobulin" (antithymocyte globulin, rabbit) at its Waterford, Ireland facility. The approval allows Genzyme to begin manufacturing and distribution of Thymoglobulin from this facility.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London) has reissued its recall of a specific batch of counterfeit ?Lipitor? 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.

Roxane Laboratories (Columbus, OH), a Boehringer Ingelheim company, is conducting a voluntary recall in the United States and Puerto Rico of a single manufacturing lot of "Azathioprine"tablets, USP 50 mg.

Seeking more than $5.8 million in damages and the recovery of nearly $1.8 billion in punitive damages, RxUSA Wholesale (Port Washington, NY) filed a complaint against 16 major US pharmaceutical manufacturers and 5 drug wholesalers.

Dietmar Hopp, cofounder of the German information technology giant SAP AG (Waldorff, Germany) is forming a new pharmaceutical company from the merger of two German biopharmaceutical companies: Axaron Bioscience AG (Heidelberg, Germany) and Lion Bioscience AG (Heidelberg, Germany).

Novartis (Basel, Switzerland) will build a cell culture-derived influenza vaccines manufacturing plant in Holly Springs, North Carolina. Construction is expected to begin in 2007.

In a move to strengthen its position in Western generic drug markets, Ranbaxy Laboratories Ltd. (Gurgaon, Haryana, India) acquired the Mundogen generic drug business of GlaxoSmithKline (GSK, London, England) in Spain, through Ranbaxy's Spanish subsidiary, Laboratorios Ranbaxy S.L.

A group of researchers from Georgia Institute of Technology (Atlanta, GA) are using high-throughput ionization techniques to identify and measure the ingredients in counterfeit drugs.

Although the number of anti-infective vaccines (as distinct from therapeutic vaccines for cancers and other noninfectious diseases) entering clinical study each year since 2000 has been higher on average than it was in the 1990s, this product area may see little additional growth through the rest of this decade, according to a recentanalysis from the Tufts Center for the Study of Drug Development (Boston, MA).

The Bayer Group (Leverkusen, Germany) plans to sell the diagnostics division of Bayer HealthCare to Siemens AG (Munich, Germany) for EUR 4.2 billion ($5.36 billion).

Vaccine maker Sanofi Pasteur, Inc. received a US Food and Drug Administration Warning Letter, dated June 30, citing "significant deviations" from current good manufacturing practices in the production of monovalent concentrates used in the company?s ?Fluzone? influenza vaccine.