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The safe use of microorganisms for the manufacture of biological Pharmaceuticals has been demonstrated over several decades. Regulations, guidelines, and codes of practice are already available, and additional guidance is being published by a variety of organizations worldwide.
The implications of these regulations are reviewed and their impact is described using examples of facility, equipment, and process design, with particular emphasis on containment.
bioprocessing, biotechnology, containment
Head, Engineering and Fermentation, Wellcome Biotechnology Ltd., Beckenham, Kent