MTU Library Catalogue

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Filtration and purification in the biopharmaceutical industry / edited by Maik W. Jornitz.

Contributor(s): Jornitz, Maik W, 1961- [editor].
Material type: materialTypeLabelBookSeries: Drugs and the pharmaceutical sciences: Publisher: Boca Raton : CRC Press, Taylor & Francis Group, 2022Copyright date: ©2020Edition: Third edition.Description: xviii, 653 pages : illustrations, 26 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 9781032338286 (paperback); 1032338288 (paperback).Subject(s): Biological products -- Separation | Filters and filtration | Pharmaceutical biotechnology -- MethodologyAdditional physical formats: Electronic Version: Filtration and purification in the biopharmaceutical industryDDC classification: 615.19 | 615.19 FIL Also available in electronic form.
Contents:
Prefiltration in biopharmaceutical processes -- Charge-modified filter media -- Filter designs -- Membrane pore structure and distribution -- Filtrative particle removal -- Microbiological considerations in the selection and validation of filter sterilization -- Filter configuration choices and sizing requirements -- Stainless steel application and fabrication in the biotech industry -- Protein adsorption on membrane filters -- Integrity testing -- Filter manufacturer’s quality assurance and qualifications -- Validation of the filter and of the filtration process -- Extractables and leachables evaluations for filters -- Media and buffer filtration requirements -- Downstream processing -- Ultrafiltration and crossflow microfiltration filtration -- Virological safety of biopharmaceuticals: how safe is safe enough -- A rapid method for purifying escherichia coli β-galactosidase using gel-filtration chromatography -- Membrane chromatography -- Expanded polytetrafluoroethylene membranes and their applications -- Gas filtration applications in the pharmaceutical industry -- Sterility testing by filtration in the pharmaceutical industry -- Bacterial biofilms in pharmaceutical water systems -- Ozone applications in biotech and pharmaceuticals -- Disposable equipment in advanced aseptic technology.
Holdings
Item type Current library Call number Status Notes Barcode
General lending MTU Bishopstown Library Lending 615.19 (Browse shelf(Opens below)) Available MTU CORK Module BIOM8001 - Supplementary 00220188
General lending MTU Kerry North Campus Library First Floor Main 615.19 FIL (Browse shelf(Opens below)) Available MTU Kerry Module PHRM81006 - Recommended reading. 38888000956817
Total holds: 0

Enhanced descriptions from Syndetics:

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.

Includes bibliographical references and index.

Prefiltration in biopharmaceutical processes -- Charge-modified filter media -- Filter designs -- Membrane pore structure and distribution -- Filtrative particle removal -- Microbiological considerations in the selection and validation of filter sterilization -- Filter configuration choices and sizing requirements -- Stainless steel application and fabrication in the biotech industry -- Protein adsorption on membrane filters -- Integrity testing -- Filter manufacturer’s quality assurance and qualifications -- Validation of the filter and of the filtration process -- Extractables and leachables evaluations for filters -- Media and buffer filtration requirements -- Downstream processing -- Ultrafiltration and crossflow microfiltration filtration -- Virological safety of biopharmaceuticals: how safe is safe enough -- A rapid method for purifying escherichia coli β-galactosidase using gel-filtration chromatography -- Membrane chromatography -- Expanded polytetrafluoroethylene membranes and their applications -- Gas filtration applications in the pharmaceutical industry -- Sterility testing by filtration in the pharmaceutical industry -- Bacterial biofilms in pharmaceutical water systems -- Ozone applications in biotech and pharmaceuticals -- Disposable equipment in advanced aseptic technology.

MTU CORK Module BIOM8001 - Supplementary reading.

MTU Kerry Module PHRM81006 - Recommended reading.

Also available in electronic form.

Table of contents provided by Syndetics

  • Foreword (p. ix)
  • Acknowledgments (p. xi)
  • Summary (p. xiii)
  • Editor (p. xv)
  • Contributors (p. xvii)
  • 1 Prefiltration in Biopharmaceutical Processes (p. 1)
  • 2 Charge-Modified Filter Media (p. 21)
  • 3 Filter Designs (p. 41)
  • 4 Membrane Pore Structure and Distribution (p. 57)
  • 5 Filtrative Particle Removal (p. 73)
  • 6 Microbiological Considerations in the Selection and Validation of Filter Sterilization (p. 131)
  • 7 Filter Configuration Choices and Sizing Requirements (p. 141)
  • 8 Stainless Steel Application and Fabrication in the Biotech Industry (p. 169)
  • 9 Protein Adsorption on Membrane Filters (p. 191)
  • 10 Integrity Testing (p. 221)
  • 11 Filter Manufacturer's Quality Assurance and Qualifications (p. 277)
  • 12 Validation of the Filter and of the Filtration Process (p. 295)
  • 13 Extractables and Leachables Evaluations for Filters (p. 309)
  • 14 Media and Buffer Filtration Requirements (p. 331)
  • 15 Downstream Processing (p. 349)
  • 16 Ultrafiltration and Crossflow Microfiltration Filtration (p. 383)
  • 17 Virological Safety of Biopharmaceuticals: How Safe Is Safe Enough? (p. 437)
  • 18 A Rapid Method for Purifying Escherichia coli ß-galactosidase Using Gel-Filtration Chromatography (p. 467)
  • 19 Membrane Chromatography (p. 481)
  • 20 Expanded Polytetrafluoroethylene Membranes and Their Applications (p. 503)
  • 21 Gas Filtration Applications in the Pharmaceutical Industry (p. 519)
  • 22 Sterility Testing by Filtration in the Pharmaceutical Industry (p. 571)
  • 23 Bacterial Biofilms in Pharmaceutical Water Systems (p. 587)
  • 24 Ozone Applications in Biotech and Pharmaceuticals (p. 609)
  • 25 Disposable Equipment in Advanced Aseptic Technology (p. 627)
  • Index (p. 639)

Author notes provided by Syndetics

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.