ABSTRACT

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness wh

chapter 2|11 pages

A Biotech Validation Concept

chapter 5|23 pages

Cell Line Characterization

chapter 6|28 pages

Process Validation and Characterization

chapter 7|14 pages

Recovery Operations

chapter 8|13 pages

Purification Issues

chapter 10|15 pages

Chromatography Media Lifetime

chapter 11|21 pages

Validation of Filtration

chapter 12|15 pages

Cleaning

chapter 17|17 pages

Special Issues for DNA Vaccines

chapter 19|12 pages

Ex Vivo Autologous Cell Therapies