3rd Edition
Filtration and Purification in the Biopharmaceutical Industry, Third Edition
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.
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
Biography
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
