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9780470466308

Quality by Design for Biopharmaceuticals: Principles and Case Studies

by ;
  • ISBN13:

    9780470466308

  • ISBN10:

    0470466308

  • Format: eBook
  • Copyright: 2009-06-01
  • Publisher: Wiley-Interscience
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Table of Contents

Preface
Quality by Design (QbD): An Overview of the Basic Concepts
Considerations for Biotechnology Product Quality by Design
Molecular Design of Recombinant Malaria Vaccines Expressed
Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes
Case Study on Definition of Process Design Space for a Microbial Fermentation Step
Applications of Design Space for Biopharmaceutical Purification Processes
Viral Clearance: A Strategy for Quality by Design and the Design Space
Application of Quality by Design and Risk Assessment Principles for the Development of Formulation Design Space
QbD for Raw Materials
PAT Tools for Biologics: Considerations and Challenges
Evolution and Integration of Quality by Design and Process Analytical Technology
Table of Contents provided by Publisher. All Rights Reserved.

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