Archives for August 14, 2014

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Japanese biotech adopts MES at recombinant flu vaccine plant

By Zachary Brennan

Japanese biotech company Unigen has implemented in only four months Werum's PAS-X Manufacturing Execution System (MES), which can help optimize production output at the world’s largest plant for the contract manufacturing of recombinant flu vaccines.

Industry slams FDA draft guidance on biosimilarity

By Zachary Brennan

Industry groups BIO and PhRMA, as well as biotech company Genentech, are taking issue with US FDA draft guidance that is designed to help companies design and use clinical pharmacology studies to help prove that a developing biosimilar is similar to its...