Proc Valid Biophar Manu |
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| Author:
| Singh, Rathore Anurag |
| ISBN: | 978-1-57444-516-9 |
| Publication Date: | May 2005 |
| Publisher: | CRC Press LLC
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| Book Format: | Hardback |
| List Price: | USD $199.95 |
Book Description:
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Written by experts in process validation, this reference explores current trends and provides strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for...
More DescriptionWritten by experts in process validation, this reference explores current trends and provides strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages.