Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, including the current methods, processes, technologies and equipment, and brings you up-to-date with the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries.
An essential, comprehensive, source for all professionals involved with filtration and purification practices and compliance, this text
· addresses recent biotechnology-related processes and advanced technologies, such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and medium and buffer filtration
· presents detailed updates on the latest FDA and EMEA regulatory requirements involving filtration and purification practices
· describes current industry quality standards and validation requirements and provides guidance for compliance
Table of Contents
Depth and Lenticular Filtration. Prefiltration. Charge-Modified Filter Media. Filter Designs. Quality Assurance of Filter Manufacture. Pore Size and Distributions. Extractables and Compatibilities of Filters. Bacterial Biofilms. Filtrative Particle Removal. Integrity Testing. Sizing of Membrane Filter Systems. Filter Housings. Cross-Flow Filtration. Protein Adsorption on Membrane Filters. Microbial Retention Testing. Filtration of Viral Contamination. Membrane Chromatography. LAL Testing. Air Filtration in the Biopharmaceutical Industry. Sterility Testing with Membrane Filters. Cell Harvesting. Downstream Processing. Important Factors in Media and Buffer Filtration. The Filtration of Blood and Blood Fractions. The Operation of the FDA. The Operation of the EMEA. Validation of Particle Counters. Validation of Filtrative Sterilization.
“…As the authors so correctly state, the responsibility for validation remains exclusively that of the drug manufacturer. To understand the claims of the filter companies, however, the drug manufacturer needs the knowledge contained in this relevant, comprehensive book.”
—European Journal of Pharmaceutics and Biopharmaceutics (for previous edition)
“…a significant achievement documenting scientific advancements from around the world…this book [is] an essential reference for those developing and utilizing filtration technology in the biopharmaceutical industry.”
—Pharmaceutical Research (for previous edition)
“…an extremely thorough single-source coverage of the subject…highly recommended.”
—Biotechnology Advances (for previous edition)
“…an excellent reference text for the experienced process engineer or as an introduction for newcomers to the field of filtration.”
—European Journal of Parenteral Sciences (for previous edition)