New EMA draft guidance on biopharma manufacturing in transgenic animals
EMA, in the Executive Summary to this guidelines states “Transgenic animal technology has emerged as a complement to the longer-established range of prokaryotic, yeast and mammalian cell-based recombinant protein expression systems for the production of therapeutic proteins. In this document guidance is provided on the approaches that should be employed in order to achieve satisfactory quality for biological drug substances proposed to be produced using this technology.”
To see the draft guidance: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127961.pdf
Look for a comprehensive discussion of this new guidance in our June issue. To subscribe: www.bioquality.biz
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