[PDF.29sq] Making monoclonal antobodies: A CMC strategy and QbD approach

Making monoclonal antobodies: A CMC strategy and QbD approach

[PDF.zi05] Making monoclonal antobodies: A CMC strategy and QbD approach

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 | #5159669 in Books |  2012-10-29 | Original language:English | PDF # 1 |  9.00 x.24 x6.00l, | File type: PDF | 104 pages

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||About the Author|Wei Xu is Research Manager at the Global Risk Institute (GRI), Toronto. Before joining GRI, Dr Xu was a Visiting Professor at the University of Waterloo. Previously, he was an Associate Professor at Tongji University, Shanghai. He co-founded Sha

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.

You can specify the type of files you want, for your device.Making monoclonal antobodies: A CMC strategy and QbD approach   |  Wei Xu. I have read it a couple of times and even shared with my family members. Really good. Couldnt put it down.

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