Quality by design for biopharmaceuticals: principles and case studies
Rathore, Anurag S.
Mhatre, Rohin
105,13 €(IVA inc.)
This book will provide an in-depth understanding of the underlying concepts of QbD and the practical aspects in the implementation of QbD for biopharmaceutical manufacturing. The reader will be led through a stepwise QbD process outlining the understanding of 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 ofQbD for routine manufacturing. Case studies will be provided by experts in leading biotechnology companies world-wide to further enhance the understanding of QbD and provide the reader with real-world examples of the various aspects of QbD.
- ISBN: 978-0-470-28233-5
- Editorial: John Wiley & Sons
- Encuadernacion: Cartoné
- Páginas: 312
- Fecha Publicación: 26/06/2009
- Nº Volúmenes: 1
- Idioma: Inglés