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.
- ISBN10 0470887214
- ISBN13 9780470887219
- Publish Date 15 May 2020
- Publish Status Cancelled
- Publish Country US
- Publisher John Wiley and Sons Ltd
- Imprint Wiley-Blackwell
- Format Hardcover
- Pages 300
- Language English