Making Monoclonal Antobodies : A CMC Strategy and QbD Approach

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Author(s):	Xu, Wei
ISBN No.:	9781480072077
Pages:	104
Year:	201210
Format:	Trade Paper
Price:	$ 53.82
Dispatch delay:	Dispatched between 7 to 15 days
Status:	Available (On Demand)

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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.

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