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Filtration and Purification in the Biopharmaceutical Industry, Third Edition


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Table of Contents

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

About the Author

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

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