Quality by Design for Biopharmaceuticals : Principles and Case Studies Hardback
Edited by Anurag S. Rathore, Rohin Mhatre
Part of the Wiley Series in Biotechnology and Bioengineering series
This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing.
A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the 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.
Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
- Format: Hardback
- Pages: 312 pages, Illustrations
- Publisher: John Wiley and Sons Ltd
- Publication Date: 01/07/2009
- Category: Clinical trials
- ISBN: 9780470282335