3rd Edition

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

Edited By

Maik W. Jornitz




ISBN 9781138056749
Published July 12, 2019 by CRC Press
672 Pages 400 B/W Illustrations

USD $259.95

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Book Description

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.

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

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Editor(s)

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

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Author - Maik  Jornitz
Editor

Maik Jornitz

Founder, BioProcess Resources LLC
Manorville, NY, USA

Learn more about Maik Jornitz »