Filtration and Purification in the Biopharmaceutical Industry, Third Edition: 3rd Edition (Hardback) book cover

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

3rd Edition

Edited by Maik W. Jornitz

CRC Press

660 pages | 400 B/W Illus.

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Hardback: 9781138056749
pub: 2019-06-12
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Description

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 this field including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. An essential, comprehensive source for all professionals involved with filtration and purification practices and compliance, this text describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and buffer filtration.

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 Editor

Maik J. Jornitz is the CEO of Leading Autonomous Cleanroom Designs, G-CON Manufacturing Inc., Texas

About the Series

Drugs and the Pharmaceutical Sciences

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy
SCI010000
SCIENCE / Biotechnology