Filtration In The Biopharmaceutical Industry

Author : Maik J. Jornitz
Publisher : CRC Press
ISBN 13 : 0849379547
Total Pages : 816 pages
Book Rating : 4.43/5 ( download)

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Download or read book Filtration and Purification in the Biopharmaceutical Industry written by Maik J. Jornitz and published by CRC Press. This book was released on 2007-11-28 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, in

Author : Theodore H. Meltzer
Publisher : CRC Press
ISBN 13 : 9780824798963
Total Pages : 950 pages
Book Rating : 4.61/5 ( download)

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Download or read book Filtration in the Biopharmaceutical Industry written by Theodore H. Meltzer and published by CRC Press. This book was released on 1998-01-05 with total page 950 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offering a comprehensive examination of developments in the field, this book delineates filtration in a host of applications. Addressing quality, security, economic, process development, and regulatory topics, the book covers pre- and sterility grade filters, charge-modified filter media, and aids to filtration, discusses filter quality assurance, pore size, extractables, and compatibilities in various filters, examines filter design and construction, analyzes integrity testing, test sensitivity, and automation, furnishes novel filtration flow methods, explains filter validation, summarizes the U.S. Food and Drug Administration regulations governing filtration, and more.

Author : Maik W. Jornitz
Publisher : CRC Press
ISBN 13 : 1351675699
Total Pages : 673 pages
Book Rating : 4.97/5 ( download)

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Download or read book Filtration and Purification in the Biopharmaceutical Industry, Third Edition written by Maik W. Jornitz and published by CRC Press. This book was released on 2019-06-26 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Maik W. Jornitz
Publisher : CRC Press
ISBN 13 : 1420030094
Total Pages : 640 pages
Book Rating : 4.99/5 ( download)

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Download or read book Sterile Filtration written by Maik W. Jornitz and published by CRC Press. This book was released on 2020-04-15 with total page 640 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration!

Author : Abhinav A. Shukla
Publisher : CRC Press
ISBN 13 : 1420016024
Total Pages : 600 pages
Book Rating : 4.24/5 ( download)

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Download or read book Process Scale Bioseparations for the Biopharmaceutical Industry written by Abhinav A. Shukla and published by CRC Press. This book was released on 2006-07-07 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceut

Author : Regine Eibl
Publisher : John Wiley & Sons
ISBN 13 : 1119477778
Total Pages : 672 pages
Book Rating : 4.78/5 ( download)

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Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.

Author : Maik W. Jornitz
Publisher : CRC Press
ISBN 13 : 9780824702823
Total Pages : 640 pages
Book Rating : 4.24/5 ( download)

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Download or read book Sterile Filtration written by Maik W. Jornitz and published by CRC Press. This book was released on 2000-12-18 with total page 640 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration! Enabling educated developmental, procedural, and regulatory judgments to be made in the manufacturing of sterile health care products, Sterile Filtration considers how many filters should be in the process stream examines the existence of nanobacteria and viable but nonculturable organisms covers pore size designations, distributions, architecture, and numbers discusses the latest findings in bubble point and diffuse flow measurements describes pre- and postfiltration, up- and downstream testing, and after-stream sterilizations details wetting liquid, polymer, temperature, and water purity effects explains sieve retention, size exclusion, adsorptive sequestrations, charge-related phenomena, gravitational settling, and interference factors in liquids and gases outlines filter validation, requirements, and operational specifics and more! Advocating separation in addition to physical destruction of microorganisms, Sterile Filtration is a reference essential for pharmaceutical scientists; biotechnologists; microbiologists; virologists; process and chemical engineers; plant, production, validation, and quality control managers in the pharmaceutical and biotechnology industries; and upper-level undergraduate and graduate school students in these disciplines.

Author : Allan Matte
Publisher : Elsevier
ISBN 13 : 0081030193
Total Pages : 222 pages
Book Rating : 4.96/5 ( download)

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Download or read book Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics written by Allan Matte and published by Elsevier. This book was released on 2020-09-07 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography

Author : Maik W. Jornitz
Publisher : Springer
ISBN 13 : 9783642066818
Total Pages : 0 pages
Book Rating : 4.1X/5 ( download)

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Download or read book Sterile Filtration written by Maik W. Jornitz and published by Springer. This book was released on 2010-02-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 1 R. Levy, M.W. Jornitz: Types of Filtration.- 2 T. Meltzer: Modus of Filtration.- 3 O.W. Reif: Microfiltration Membranes: Characteristics and Manufacturing.- 4 M. W. Jornitz: Filter Construction and Design.- 5 R. Madsen: Filter Validation.- 6 M. W.Jornitz: Integrity Testing.-

Author : Gary Gilleskie
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110617013
Total Pages : 433 pages
Book Rating : 4.16/5 ( download)

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Download or read book Biopharmaceutical Manufacturing written by Gary Gilleskie and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-09-07 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book: