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Biotechnology : Quality Assurance and Validation - Kenneth E. Avis


Quality Assurance and Validation

By: Kenneth E. Avis (Editor), Carmen M. Wagner (Editor), Vincent L. Wu (Editor)

Hardcover Published: 31st October 1998
ISBN: 9781574910896
Number Of Pages: 288

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Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.

Cryopreservation: Storage & Documentation QC & QA Issues
Manufacturing Issues: Field Investigator's Perspective
Validation of Biopharmaceutical Processes
Ensuring Virological Safety of Biologicals
Cleaning & Validation in Biopharmaceutical Processing
Table of Contents provided by Publisher. All Rights Reserved.

ISBN: 9781574910896
ISBN-10: 1574910892
Series: Drug Manufacturing Technology Series
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 288
Published: 31st October 1998
Publisher: Taylor & Francis Inc
Country of Publication: US
Dimensions (cm): 24.13 x 16.51  x 2.54
Weight (kg): 0.59
Edition Number: 1