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PAT Applied in Biopharmaceutical Process Development And Manufacturing : An Enabling Tool for Quality-by-Design, PDF eBook

PAT Applied in Biopharmaceutical Process Development And Manufacturing : An Enabling Tool for Quality-by-Design PDF

Edited by Cenk Undey, Duncan Low, Jose C. Menezes, Mel Koch

Part of the Biotechnology and Bioprocessing series

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As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH).

Given the rapid growth in the biopharmaceutical area and the comp

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