Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

1st Edition

Gail Sofer

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CRC Press
Published March 24, 2000
Reference - 402 Pages
ISBN 9780429136276 - CAT# KE81125

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Summary

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness wh

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