Manufacturing

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

London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials.

Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.

Argonne, IL (Nov. 9)-Researchers from Argonne National Laboratory?s Chemistry Division and Xradia have developed a novel X-ray microscopy technique that allows molecular observations of the reactivity of solid surfaces at the nanometer scale, including interfacial reactions such as ion adsorption and catalytic reactions.

Washington, DC (Nov. 20)-The US Department of Health and Human Services awarded contracts totaling $199.45 million to Sanofi Pasteur, Novartis, and GlaxoSmithKline PLC to manufacture 5.3 million 90-?g doses of influenza vaccine designed to protect against the H5N1 influenza virus strain.

Alcan, China Biopharma, US FDA, MedImmune, more

Leverkusen, Germany (Nov. 9)?Bayer AG outlined its strategy for integrating Schering AG (Berlin) into the newly formed company, Bayer Schering Pharma. These moves follow Bayer's acquisition of Schering AG earlier this year.

Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.

South San Francisco, CA (Nov. 9)?Genentech, Inc. has agreed to acquire Tanox, Inc., for $20 per share, a total cash value of roughly $919 million. Tanox is a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology.

Mystic, CT (Oct. 26)-Kenneth G. Chapman died at his home here on Oct. 26. He was 79. The cause was pancreatic cancer

Research Triangle Park, NC (Nov. 13)-Eisai Inc. broke ground here for a new pharmaceutical production and formulation research and development facility for parenteral oncology drugs.

AAPS, San Antonio (Oct. 31-The advantages of ultra-performance liquid chromatography over traditional high-performance liquid chromatographic were the center of the presentation, ?Strategies for Rapid Chromatographic Method Development from Preclinical to Phase 3,? by Charanjeet Jassal of Wyeth Pharmaceuticals.

Geneva, Switzerland (Oct. 23)-Aiming to increase capacity for producing influenza pandemic vaccines, the World Health Organization has identified strategies and practical solutions for reducing the anticipated gap in the global vaccine supply.

Dublin, Ireland (Nov. 6)-Merck Sharp & Dohme (Ireland) Ltd., a wholly owned subsidiary of Merck & Co, Inc. plans to establish a formulation-research-and-development and manufacturing facility at its plant in Ballydine, Ireland, according to the Industrial Development Agency Ireland.

Akorn, Natco, Illumigen, Avecia

AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.

South San Francisco, CA and Basel, Switzerland (Nov. 8)-Genentech, Inc. and the contract manufacturer Lonza Group entered into an agreement under which Lonza will buy Genentech's mid-scale mammalian biopharmaceutical manufacturing facility in Porri?o, Spain, supply certain products to Genentech, and provide Genentech with the option to purchase Lonza's planned biopharmaceutical manufacturing facility in Singapore.

AAPS, San Antonio (Oct. 30)-Although the analysis of impurities in drug substances and drug products is not a new topic, new regulations are increasing concern in the industry.

AAPS, San Antonio (Oct. 31)-As biologic-based drugs become an increasingly larger part of pharmaceutical product portfolios, strategies for optimizing their formulation become increasingly important.

AAPS, San Antonio (Oct. 30)-Aiming to provide a greater understanding of coating processes, speakers at the 20th Annual Meeting of the American Association of Pharmaceutical Scientists presented some of the difficulties, tools, and strategies for obtaining adequately uniform films in pan and fluid-bed coating processes.

San Antonio, TX (Nov. 1)-Though the US Food and Drug Administration's final guidance on process analytical technology (PAT) was published in Sept. 2004, companies are still unsure about how exactly to implement PAT in their processes.