Biotechnology: Quality Assurance and Validation / Edition 1

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

Overview

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.

Product Details

ISBN-13:	9781574910896
Publisher:	Taylor & Francis
Publication date:	10/31/1998
Series:	Drug Manufacturing Technology Ser.
Pages:	288
Product dimensions:	6.00(w) x 9.00(h) x 0.90(d)

About the Author

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

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.

Editorial Reviews

Addresses selected quality and validation issues facing biotechnology companies producing biopharmaceutical products. Among them are storage and documentation systems for cryopreservation, processing, a field investigator's perspective on manufacturing issues, removing viruses from biological fluids by filtration, cleaning and its validation. As an example of the more detailed topics considered, the chapter on validating biopharmaceutical processes discusses cell bank testing and qualification, equipment qualification, validating fermentation and cell-culture processes, validating downstream processing, performance qualification of downstream processes, clearance studies, and validating tangential flow filtration. Annotation c. by Book News, Inc., Portland, Or.

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