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Pharmaceutical Manufacturing and Packing Sourcer

Primary Production of Biopharmaceuticals in Plants - An Economically Attractive Choice?

Plants as Alternative Eukaryotic Expression Systems

The progress of molecular plant genetics, and particularly of transgene expression in plants, has spurred the interest of academia and companies to consider them as eukaryotic hosts for biopharmaceutical production and as an additional or even alternative system to established mammalian cell culture (CHO) and yeast fermentation (1). Two arguments favouring plant hosts have frequently been quoted, namely safety - the absence of adventitious mammalian viral or prionic contamination - and the unlimited scalability of production.

Whether the future launch of biogenerics and the market introduction of numerous new therapeutic monoclonal antibodies will really be accompanied by a strong capacity shortage in primary production, as often predicted, is as yet uncertain. Therefore it is worthwhile to analyse whether plant expression systems have the potential to become an additional sourcing route for biopharmaceutical active ingredients in collaboration with, and as a feasible technological extension of, established mammalian cell culture and microbial fermentation.

From the viewpoint of the pharmaceutical industry, the prerequisites that a new expression system must fulfil are as follows:


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By Dr Detlef Wilke, Partner at Biotech Consulting GmbH and Jens A Katzek, Managing Director of BIO-Mitteldeutschland GmbH

Dr Detlef Wilke is a Microbiologist, and since 1992 has operated a consulting company specialising in biotechnology. Together with his partners at the firm, he published technology and cost structure analysis of recombinant and conventional biotech products. Prior to his consulting business he worked for 15 years in R&D and business development with Schering AG and Solvay & Cie. In June 2003 he became a Member of the management board of Icon Genetics AG, Munich.

Dr Jens A Katzek is a Biochemist, and since January 2003 has been Managing Director of BIO-Mitteldeutschland GmbH. Prior to this position he was Managing Director of the German Association of Biotechnology Industries (DIB), has worked as the Head of Corporate Communications with the seed company KWS SAAT AG, and was responsible for the international environmental policy of BUND - Friends of the Earth, Germany.


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Dr Detlef Wilke
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Dr Jens A Katzek
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