Biotechnology: Quality Assurance and Validation, 1st Edition (Hardback) book cover


Quality Assurance and Validation, 1st Edition

Edited by Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu

CRC Press

288 pages

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Hardback: 9781574910896
pub: 1998-10-31
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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.

Table of Contents


Cryopreservation: Storage & Documentation, F. Simione

QC & QA Issues, G. Christiansen

Manufacturing Issues: Field Investigator's Perspective, G. Bobrowicz

Validation of Biopharmaceutical Processes, H. Levine & F. Castillo

Ensuring Virological Safety of Biologicals, H. Aranha-Creado

Cleaning & Validation in Biopharmaceutical Processing, J. Voss &

R. O'Brien

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology