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