Mel (University of Washington, Seattle, USA) Koch & Duncan (Amgen, Thousand Oaks, California, USA) Low 
PAT Applied in Biopharmaceutical Process Development And Manufacturing [PDF ebook] 
An Enabling Tool for Quality-by-Design

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 (Qb D) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the comp