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


Quality Assurance and Validation, 1st Edition

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

CRC Press

288 pages

Purchasing Options:$ = USD
Paperback: 9780367400255
pub: 2019-09-11
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

QC & QA Issues. Manufacturing Issues: Field Investigator's Perspective. Validation of Biopharmaceutical Processes. Ensuring Virological Safety of Biologicals. Cleaning & Validation in Biopharmaceutical Processing.

About the Editors

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

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Life Sciences / General