The fourth edition of Process Validation in Manufacturing of
Biopharmaceuticals is a practical and comprehensive resource
illustrating the different approaches for successful validation of
biopharmaceutical processes. A pivotal text in its field, this new
edition provides guidelines and current practices, industrial case
studies, and is expanded to include in-depth analysis of the new
Process Validation (PV) guidance from the US FDA. Key Features:
Offers readers a thorough understanding of the key concepts that
form the basis of a good process validation program. Includes case
studies from the various industry leaders that demonstrate
application of these concepts Discusses the use of modern tools
such as multivariate analysis for facilitating a process validation
exercise Covers process characterization techniques for scaling
down unit operations in biopharmaceutical manufacturing, including
chromatography, chemical modification reactions, ultrafiltration,
and microfiltration, and practical methods to test raw materials
and in-process samples. Providing a thorough understanding of the
key concepts that form the basis of a good process validation
program, this book will help readers ensure that PV is carried out
and exceeds expectations. Fully illustrated, this is a much-needed
practical guide for biopharmaceutical manufacturers.
General
| Imprint: |
Crc Press
|
| Country of origin: |
United Kingdom |
| Series: |
Biotechnology and Bioprocessing |
| Release date: |
December 2023 |
| First published: |
2024 |
| Editors: |
Anurag Singh Rathore
• Harold Baseman
• Scott Rudge
|
| Dimensions: |
254 x 178mm (L x W) |
| Pages: |
552 |
| Edition: |
4th edition |
| ISBN-13: |
978-0-367-69762-4 |
| Categories: |
Books
|
| LSN: |
0-367-69762-9 |
| Barcode: |
9780367697624 |
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