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home > pmps > spring 2003 > current good manufacturing practice for biological apis

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Pharmaceutical Manufacturing and Packing Sourcer Current Good Manufacturing Practice for Biological APIs
Biological manufacturing is currently in the spotlight for several reasons. The pipeline of new pharmaceuticals is reported to contain nearly 1,000 biotechnology based products(1) whilst biotechnology-based products constitute then about 30 per cent of the total pharmaceutical pipeline. The expectations of biotechnology products are growing as they enter late stage clinical phases. Over recent years, the average number of approved biotechnology-based drugs has been around 30 per year. The increase in approved products has, for monoclonal antibodies (MAb) and other recombinant proteins produced by mammalian cell culture, led to a production capacity shortage being reported by several consultants. Microbially derived products donÕt seem as affected, but manufacturing using microbial systems requires as much planning and preparation, even if capacity shortage is not obvious.
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By Liselotte Larsson PhD, Marketing and Sales at Novozymes Biopharma AB

Liselotte Larsson PhD has been responsible for marketing and sales at Novozymes Biopharma AB and its predecessors since 1996.

Prior to her employment with Novozymes Biopharma, Dr Larsson worked for The Swedish Technical AttachŽs and for the Swedish environmental authorities. Dr Larsson gained her PhD in Biotechnology at Lund University, Sweden and became involved with marketing after joining the company.