Filtration and Purification in the Biopharmaceutical Industry, Second Edition

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Maik J. Jornitz, Theodore H. Meltzer
CRC Press, Nov 28, 2007 - Medical - 816 pages
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Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, including the current methods, processes, technologies and equipment, and brings you up-to-date with the latest 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

addresses recent biotechnology-related processes and advanced technologies, such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and medium and buffer filtration

presents detailed updates on the latest FDA and EMEA regulatory requirements involving filtration and purification practices

describes current industry quality standards and validation requirements and provides guidance for compliance

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Contents

Chapter 1 Prefiltration in Biopharmaceutical Processes
1
Chapter 2 Charge Modified Filter Media
23
Chapter 3 Filter Designs
47
Chapter 4 Pore Size and Distributions
65
Chapter 5 Concerning Mechanisms of Particle Removal by Filters
81
Chapter 6 Microbiological Considerations in the Selection and Validation of Filter Sterilization
151
The Requirements and Their Attainment
163
Chapter 8 Filter Housing in the Biopharmaceutical Industry
193
Chapter 17 Media and Buffer Filtration Implications
439
Chapter 18 Downstream Processing
459
Chapter 19 Crossflow Filtration
495
Virus and Prion Safety Considerations
543
Chapter 21 A Rapid Method for Purifying Escherichia coli Galactosidase Using GelFiltration Chromatography
579
Chapter 22 Membrane Chromatography
597
Chapter 23 Expanded Polytetrafluoroethylene Membranes and Their Applications
619
Chapter 24 Air Filtration Applications in the Pharmaceutical Industry
641

Chapter 9 Stainless Steel Application and Fabrication in the Biotech Industry
231
Chapter 10 Protein Adsorption by Polymeric Filters
257
Chapter 11 The Filter Integrity Tests
297
Chapter 12 FIlter Manufacture Quality Assurance and Validation
351
Chapter 13 Validation of the Filter and of the Filtration Process
371
Chapter 14 Extractables and Leachable Evaluations for Filters
389
Chapter 15 Endotoxin Limulus Amebocyte Lysate and Filter Applications
413
Chapter 16 Limulus Amebocyte Lysate Assays and Filter Applications
425
Chapter 25 Sterility Testing by Filtration in the Pharmaceutical Industry
681
Chapter 26 Bacterial Biofilms in Pharmceutical Water Systems
699
Chapter 27 Steam Sterilization of Filters
717
Chapter 28 Ozone Applications in Biotech and Pharmaceuticals
753
Index
773
Back cover
791
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