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.

chapter 1|6 pages


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

chapter 2|25 pages

Cryopreservation: Storage and Documentation Systems

ByFrank P. Simione

chapter 3|39 pages

Quality Control and Quality Assurance Issues in Biopharmaceutical Processing

ByGary D. Christiansen

chapter 4|38 pages

Biotechnology Manufacturing Issues: A Field Investigator’s Perspective

ByGregory Bobrowicz

chapter 5|55 pages

Validation of Biopharmaceutical Processes

ByHoward L. Levine, Francisco J. Castillo

chapter 7|30 pages

Cleaning and Validation of Cleaning in Biopharmaceutical Processing: A Survey

ByJon R. Voss, Robert W. O’Brien