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January 04, 2008
Merck Sells Facility to Cherokee Pharmaceuticals, Inflazyme Announces Senior Management Resignations, More...
January 02, 2008
There is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.
FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.
News, world briefs, facility roundup, events and other items for January 2008.
January 01, 2008
The use of viral vectors as gene delivery and vaccine vehicles has developed rapidly during the last two decades owing to several viral properties. Viruses can infect cells efficiently, often have a broad tissue tropism and can achieve very high levels of either stable or transient transgene expression. Furthermore, their intrinsic immune-stimulatory properties can have adjuvant effects during the treatment of cancer or infectious disease and, importantly for manufacturing scale-up, some viruses can be grown to very high titre (.1012 particles/mL). The development of robust production procedures is essential to move therapeutics that utilize viral vectors into clinical trials, and to make them cost effective for market supply. Here, we describe some of the aspects of production that must be considered and optimized when producing virus vectors on an intermediate or large scale. By drawing examples from our experience of vector production, we show that upstream and downstream processes must be designed..
December 28, 2007
Millipore and Novozymes Form Alliance, Applied Biosystems Names President and CEO, More
December 20, 2007
Company and People Notes: West to reduce workforce, Eli Lilly's CEO and chairman to retire, more...
December 13, 2007
Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.
Company and People Notes: Eisai Acquires MGI Pharma, Ceregene Names CEO, More
December 07, 2007
Researchers at the University of Kentucky (KY, USA) have located a gene that kills cancer cells while leaving normal cells intact.