[PDF.45xz] PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design (Biotechnology and Bioprocessing)

PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design (Biotechnology and Bioprocessing)

[PDF.ap66] PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design (Biotechnology and Bioprocessing)

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 | #2820412 in Books |  2011-12-07 | Original language:English | PDF # 1 |  .90 x6.40 x9.30l,1.30 | File type: PDF | 327 pages

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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 complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proact...

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