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Filtration and Purification in the Biopharmaceutical Industry, Third Edition 3rd New edition [Hardback]

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  • Formāts: Hardback, 660 pages, height x width: 254x178 mm, 41 Tables, black and white; 400 Illustrations, black and white
  • Sērija : Drugs and the Pharmaceutical Sciences
  • Izdošanas datums: 12-Jun-2019
  • Izdevniecība: CRC Press
  • ISBN-10: 113805674X
  • ISBN-13: 9781138056749
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  • Cena: 271,09 €
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  • Bibliotēkām
  • Formāts: Hardback, 660 pages, height x width: 254x178 mm, 41 Tables, black and white; 400 Illustrations, black and white
  • Sērija : Drugs and the Pharmaceutical Sciences
  • Izdošanas datums: 12-Jun-2019
  • Izdevniecība: CRC Press
  • ISBN-10: 113805674X
  • ISBN-13: 9781138056749
Citas grāmatas par šo tēmu:
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.
Foreword ix
Acknowledgments xi
Summary xiii
Editor xv
Contributors xvii
1 Prefiltration in Biopharmaceutical Processes
1(20)
George Quigley
2 Charge-Modified Filter Media
21(20)
Eugene A. Ostreicher
Todd E. Arnold
Robert S. Conway
3 Filter Designs
41(16)
Maik W. Jornitz
4 Membrane Pore Structure and Distribution
57(16)
Maik W. Jornitz
5 Filtrative Particle Removal
73(58)
Ross Acucena
6 Microbiological Considerations in the Selection and Validation of Filter Sterilization
131(10)
James A. Akers
7 Filter Configuration Choices and Sizing Requirements
141(28)
Maik W. Jornitz
8 Stainless Steel Application and Fabrication in the Biotech Industry
169(22)
Joseph Manfredi
9 Protein Adsorption on Membrane Filters
191(30)
Maik W. Jornitz
10 Integrity Testing
221(56)
Magnus Andreas Stering
11 Filter Manufacturer's Quality Assurance and Qualifications
277(18)
Maik W. Jornitz
12 Validation of the Filter and of the Filtration Process
295(14)
Paul S. Stinavage
13 Extractables and Leachables Evaluations for Filters
309(22)
Raymond H. Colton
Denise G. Bestwick
14 Media and Buffer Filtration Requirements
331(18)
Maik W. Jornitz
15 Downstream Processing
349(34)
Uwe Gottschalk
16 Ultrafiltration and Crossflow Microfiltration Filtration
383(54)
Michael Dosmar
Steven Pinto
Kirsten Jones Seymour
17 Virological Safety of Biopharmaceuticals: How Safe Is Safe Enough?
437(30)
Hazel Aranha
18 A Rapid Method for Purifying Escherichia coli β-galactosidase Using Gel-Filtration Chromatography
467(14)
Lynn P. Elwell
19 Membrane Chromatography
481(22)
Sherri Dolan
Susan Martin
20 Expanded Polytetrafluoroethylene Membranes and Their Applications
503(16)
Michael Wikol
Bryce Hartmann
Michael Debes
Cherish Robinson
Scott Ross
Uwe Beuscher
21 Gas Filtration Applications in the Pharmaceutical Industry
519(52)
Elisabeth Jander
22 Sterility Testing by Filtration in the Pharmaceutical Industry
571(16)
Olivier Guenec
23 Bacterial Biofilms in Pharmaceutical Water Systems
587(22)
Marc W. Mittelman
24 Ozone Applications in Biotech and Pharmaceuticals
609(18)
Joseph Manfredi
25 Disposable Equipment in Advanced Aseptic Technology
627(12)
Maik W. Jornitz
Peter Makowenskyj
Index 639
Maik J. Jornitz is the CEO of Leading Autonomous Cleanroom Designs, G-CON Manufacturing Inc., Texas