PAT Applied in Biopharmaceutical Process Development And Manufacturing An Enabling Tool for Quality-by-Design 1st Edition – PDF/EPUB Version Downloadable

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