Gebundenes Buch

Quality by Design for Biopharmaceuticals

Principles and Case Studies

Herausgegeben von Rathore, Anurag S.; Mhatre, Rohin
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- Provides an in-depth understanding of the underlying concepts of Quality by Design (QbD) and the practical aspects of the implementation of QbD in biopharmaceutical manufacturing.
- Outlines the critical quality attributes for the molecule, development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management and the application of QbD for routine manufacturing
- Case studies are provided e to further enhance the understanding of QbD and provide the reader with "real-world" examples of its various aspects