Filtration and Purification in the Biopharmaceutical Industry, Third Edition

ISBN-13: 9781032338286 / Angielski / Miękka / 2022 / 672 str.

Maik W. Jornitz

Opis

The third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of this field including the current methods, pro

Spis treści

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

O autorze

Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc. and founder of Bioprocess Resources LLC, is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 10 books, 15 book chapters and over 100 scientific papers. He is Chair of the PDA Science Advisory Board, member of multiple PDA Task Forces. He is working member of BPOG, ASTM, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland