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Making monoclonal antobodies - Wei Xu - Bog

- A CMC strategy and QbD approach

af Wei Xu
Making monoclonal antobodies af Wei Xu
Bag om Making monoclonal antobodies

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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  • Sprog:
  • Engelsk
  • ISBN:
  • 9781480072077
  • Indbinding:
  • Paperback
  • Sideantal:
  • 104
  • Udgivet:
  • 29. Oktober 2012
  • Størrelse:
  • 152x229x6 mm.
  • Vægt:
  • 150 g.
  • 2-3 uger.
  • 4. Juni 2024
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Beskrivelse af Making monoclonal antobodies

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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