Abstract:Modeling approaches play a valuable role at various stages of development and life-cycle management of biopharmaceutical products. In Quality-by-Design (QbD) paradigm, quality needs to be designed into the product rather than merely confirming it through end product testing; this requires in-depth understanding of the product quality and impact of manufacturing process on product quality (Group IEW 2005. Modeling strategies in support of QbD paradigm for biologics are particularly important because of the cost… Show more
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