生物製剤開発のためのQbDモデル Quality by Design Model for Biologics Drug Product Development (Wiley Series in Biotechnology and Bioengineering)

生物製剤開発のためのQbDモデル<br>Quality by Design Model for Biologics Drug Product Development (Wiley Series in Biotechnology and Bioengineering)

生物製剤開発のためのQbDモデル
Quality by Design Model for Biologics Drug Product Development (Wiley Series in Biotechnology and Bioengineering)

Singh, Satish K./ Phillips, Joseph

Wiley-Blackwell（2020/05発売）

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製本 Hardcover:ハードカバー版／ページ数 300 p.
言語 ENG
商品コード 9780470887219
DDC分類 615.19

Full Description

A set of case studies on the different aspects of biologics drug product manufacturing, the book aims to help design manufacturing processes that meet the specific quality attributes of a product. Testing should be used to confirm the quality of the product, not to find out whether it met quality parameters or not. Addressing government implementation of QbD standards around the world, this timely reference emphasizes the application of QbD principles in the production of biologics and pharmaceuticals. Targeted at professionals, students, and regulators.