Quality by Design for Biopharmaceuticals: Principles and Case Studies
| Author | : | |
| Rating | : | 4.60 (927 Votes) |
| Asin | : | 0470282339 |
| Format Type | : | paperback |
| Number of Pages | : | 328 Pages |
| Publish Date | : | 2013-06-10 |
| Language | : | English |
DESCRIPTION:
His areas of interest include process development, scale-up, technology transfer, process validation, process analytical technology, and quality by design. Mhatre is also leading the QbD initiative within Biogen Idec. He has authored several publications and been an invited speaker to numerous scientific meetings.. Rohin Mhatre is a Senior Director in the BioProcess Development department at Biogen Idec, Cambridge, Massachusetts, and has
A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation.In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as:The understanding and development of the product's critical quality attributes (CQA)Development of the design space for a manufacturing processHow to employ QbD to design a formulation processRaw material analysis and control strategy for QbDProcess Analytical Technology (PAT) and how it relates to QbDRelevant PAT tools and applications for the pharmaceutical industryThe uses of risk assessment and management in QbDFiling QbD information in regulatory documentsThe application o
Rathore, Series Editor Quality by Design for Biopharmaceuticals Principles and Case Studies Edited by Anurag S. From the Inside FlapWiley Series in Biotechnology and bioengineering Anurag S. Rathore Rohin Mhatre
S. kim said Must-read for those implementing QbD in Biologics. As a QbD evangelist myself, I highly recommend this book as a must-read to those starting QbD in Biopharmaceuticals.The Book covers: (Chapters)1. QbD: Basic Concepts (Terminologies)"Must-read for those implementing QbD in Biologics" according to S. kim. As a QbD evangelist myself, I highly recommend this book as a must-read to those starting QbD in Biopharmaceuticals.The Book covers: (Chapters)1. QbD: Basic Concepts (Terminologies)2. Considerations for Biotech Product in QbD (Steven Kozlowski, OBP of FDA is a co-author)Must-read for those implementing QbD in Biologics As a QbD evangelist myself, I highly recommend this book as a must-read to those starting QbD in Biopharmaceuticals.The Book covers: (Chapters)1. QbD: Basic Concepts (Terminologies)2. Considerations for Biotech Product in QbD (Steven Kozlowski, OBP of FDA is a co-author)3. Molecular Design o. . Molecular Design o. . Considerations for Biotech Product in QbD (Steven Kozlowski, OBP of FDA is a co-author)Must-read for those implementing QbD in Biologics As a QbD evangelist myself, I highly recommend this book as a must-read to those starting QbD in Biopharmaceuticals.The Book covers: (Chapters)1. QbD: Basic Concepts (Terminologies)2. Considerations for Biotech Product in QbD (Steven Kozlowski, OBP of FDA is a co-author)3. Molecular Design o. . Molecular Design o. Worth reading, and has good coverage of topics. Donart Caledonian Worth reading, and has good coverage of topics. It does begin getting thin towards the end, but if you are reading this review you probably already know you should buy this book.