Filtration and Purification in the Biopharmaceutical Industry, Third Edition (3^rd Ed.) Drugs and the Pharmaceutical Sciences Series

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, 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 bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration.

Features:

• Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product
• Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing
• Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement
• It discusses the advantages of single-use process technologies and the qualification needs
• Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs
• The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

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

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