Making monoclonal antobodies: A CMC strategy and QbD approach

ISBN-13: 9781480072077 / Angielski / Miękka / 2012 / 104 str.

Wei Xu

Opis

This book provides a general description of monoclonal antibody manufacturing process. The content of this book is consistent with the structure of regulatory filing Module 3 (Quality) - CMC (Chemistry, Manufacturing and Control). This book also discussed QbD (Quality by design) in Drug Substance process development.