Wiley and Sons has published the 288-page "Quality by Design for Biopharmaceuticals: Principles and Case Studies," edited by two of biopharma-QbD's leading advocates, Anurag Rathore and Rohin Mhatre.
Expect the book to become one of the definitive resources for QbD, given the impressive list of contributors. For those who don't have the $125 for the cover price right now, the Introductory Chapter by the editors may suffice; it's available here (scroll down to "Product Samples"). It's an excellent overview of basic QbD concepts such as CQA's, Design Space, raw materials and their impact on QbD, and PAT.
--Paul Thomas
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