3rd Edition

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

Edited By Maik W. Jornitz Copyright 2020
    672 Pages 400 B/W Illustrations
    by CRC Press

    672 Pages 400 B/W Illustrations
    by CRC Press

    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.


    • 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.

    Chapter 1: Prefiltration

    George Quigley

    Chapter 2: Charge-Modified Filter Media

    Robert Conway

    Chapter 3: Filter Designs

    Maik Jornitz

    Chapter 4: Pore Size and Distributions

    Maik Jornitz

    Chapter 5: Filtrative Particle Removal

    Ross Acucena

    Chapter 6: Microbial Retention Testing & Bioburden

    James Akers

    Chapter 7: Sizing of Membrane Filter Systems

    Maik Jornitz

    Chapter 8: System Design and Validation

    Joe Manfredi

    Chapter 9: Protein Adsorption on Membrane Filters

    Maik Jornitz

    Chapter 10: Integrity Testing

    Magnus Sterling

    Chapter 11: Quality Assurance of Filter Manufacture

    Maik Jornitz

    Chapter 12: Validation of Filtrative Sterilization

    Paul Stinavage

    Chapter 13: Extractables and Compatibilities of Filters

    Raymond Colton

    Chapter 14: Media and Buffer Filtration Implications

    Maik Jornitz

    Chapter 15: Downstream Processing

    Uwe Gottschalk

    Chapter 16: Cross-Flow Filtration

    Michael Dosmar

    Chapter 17: Virus Concerns in General

    Hazel Aranha

    Chapter 18: Chromatography

    Lynn Elwell

    Chapter 19: Membrane chromatography

    Sherri Dolan

    Chapter 20: Expanded PTFE Filter

    Michael Wikol, Bryce Hartmann, Michael Debes, Cherish Robinson, Scott Ross and Uwe Beuscher

    Chapter 21: Gas Filtration Applications in the Pharmaceutical Industry

    Elisabeth Jander

    Chapter 22: Sterility testing

    Olivier Guenec

    Chapter 23: Bacterial Biofilms

    Marc W. Mittelman

    Chapter 24: Ozon in Pharmaceutical Processes

    Joe Manfredi

    Chapter 25: Single-use process technology

    Peter Makowenskyj


    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