Quality by Design Model for Biologics Drug Product Development

by Satish K. Singh and Joseph Phillips

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...

• Format: Hardcover
• Language: English
• ISBN: 0470887214
• ISBN13: 9780470887219
• Release Date: May 2020
• Publisher: Wiley
• Length: 300 Pages