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Making Monoclonal Antobodies: A CMC Strategy and QbD Approach
     

Making Monoclonal Antobodies: A CMC Strategy and QbD Approach

by Wei Xu
 
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.

Overview

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.

Product Details

ISBN-13:
9781480072077
Publisher:
CreateSpace Publishing
Publication date:
10/29/2012
Pages:
104
Product dimensions:
5.40(w) x 8.40(h) x 0.60(d)

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