Filtration and Purification in the Biopharmaceutical Industry

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Publisher : CRC Press
ISBN 13 : 0849379547
Total Pages : 816 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Filtration and Purification in the Biopharmaceutical Industry by : Maik J. Jornitz

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

Filtration in the Biopharmaceutical Industry

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Publisher : CRC Press
ISBN 13 : 9780824798963
Total Pages : 950 pages
Book Rating : 4.7/5 (989 download)

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Book Synopsis Filtration in the Biopharmaceutical Industry by : Theodore H. Meltzer

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.

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

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Publisher : CRC Press
ISBN 13 : 1351675699
Total Pages : 673 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Filtration and Purification in the Biopharmaceutical Industry, Third Edition by : Maik W. Jornitz

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.

Sterile Filtration

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Publisher : CRC Press
ISBN 13 : 1000083233
Total Pages : 648 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis Sterile Filtration by : Maik W. Jornitz

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 648 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!

Sterile Filtration

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Publisher : CRC Press
ISBN 13 : 9780824702823
Total Pages : 640 pages
Book Rating : 4.7/5 (28 download)

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Book Synopsis Sterile Filtration by : Maik W. Jornitz

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.

Process Scale Bioseparations for the Biopharmaceutical Industry

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Publisher : CRC Press
ISBN 13 : 1420016024
Total Pages : 600 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Process Scale Bioseparations for the Biopharmaceutical Industry by : Abhinav A. Shukla

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

Sterile Filtration

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Author :
Publisher : Springer
ISBN 13 : 9783642066818
Total Pages : 0 pages
Book Rating : 4.0/5 (668 download)

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Book Synopsis Sterile Filtration by : Maik W. Jornitz

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.-

Single-Use Technology in Biopharmaceutical Manufacture

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Publisher : John Wiley & Sons
ISBN 13 : 1119477778
Total Pages : 672 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl

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.

Filtration in the Pharmaceutical Industry

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Publisher : CRC Press
ISBN 13 : 9780824775193
Total Pages : 1120 pages
Book Rating : 4.7/5 (751 download)

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Book Synopsis Filtration in the Pharmaceutical Industry by : Theodore H. Meltzer

Download or read book Filtration in the Pharmaceutical Industry written by Theodore H. Meltzer and published by CRC Press. This book was released on 1986-10-31 with total page 1120 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics

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Author :
Publisher : Elsevier
ISBN 13 : 0081030193
Total Pages : 222 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics by : Allan Matte

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

Biopharmaceutical Manufacturing

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Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110617013
Total Pages : 433 pages
Book Rating : 4.1/5 (16 download)

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Book Synopsis Biopharmaceutical Manufacturing by : Gary Gilleskie

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:

Process Scale Purification of Antibodies

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119126932
Total Pages : 752 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Process Scale Purification of Antibodies by : Uwe Gottschalk

Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-03-07 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing

Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization

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Publisher : John Wiley & Sons
ISBN 13 : 0470755067
Total Pages : 691 pages
Book Rating : 4.4/5 (77 download)

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Book Synopsis Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization by : Adam P. Fraise

Download or read book Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization written by Adam P. Fraise and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 691 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly respected, established text – a definitive reference in its field – covering in detail many methods of the elimination or prevention of microbial growth "highly recommended to hospital and research personnel, especially to clinical microbiologists, infectioncontrol and environmental-safety specialists, pharmacists, and dieticians." New England Journal of Medicine WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace of change in this area Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Gives practical advise on problems of disinfection and antiseptics in hospitals Discusses increasing problems of natural and acquired resistance to antibiotics New contributors give a fresh approach to the subject and ensure international coverage Systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action

Validation of tangential flow filtration in biopharmaceutical applications

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Publisher :
ISBN 13 : 9780939459254
Total Pages : 49 pages
Book Rating : 4.4/5 (592 download)

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Book Synopsis Validation of tangential flow filtration in biopharmaceutical applications by : Parenteral Drug Association (Bethesda Md). Biotechnology Task Force on Purification

Download or read book Validation of tangential flow filtration in biopharmaceutical applications written by Parenteral Drug Association (Bethesda Md). Biotechnology Task Force on Purification and published by . This book was released on 2009 with total page 49 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sterile Filtration

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Author :
Publisher : Springer
ISBN 13 : 3540330186
Total Pages : 211 pages
Book Rating : 4.5/5 (43 download)

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Book Synopsis Sterile Filtration by : Maik W. Jornitz

Download or read book Sterile Filtration written by Maik W. Jornitz and published by Springer. This book was released on 2006-01-14 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Continuous Biomanufacturing

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Publisher : John Wiley & Sons
ISBN 13 : 3527699910
Total Pages : 628 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Continuous Biomanufacturing by : Ganapathy Subramanian

Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-09-12 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

Downstream Processing of Proteins

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Publisher : Springer Science & Business Media
ISBN 13 : 1592590276
Total Pages : 233 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis Downstream Processing of Proteins by : Mohamed A. Desai

Download or read book Downstream Processing of Proteins written by Mohamed A. Desai and published by Springer Science & Business Media. This book was released on 2008-02-05 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considerable effort and time is allocated to introducing cell culture and fermentation technology to undergraduate students in academia, generally through a range of courses in industrial biotechnology and related disciplines. Similarly, a large number of textbooks are available to describe the appli- tions of these technologies in industry. However, there has been a general lack of appreciation of the significant developments in downstream processing and isolation technology, the need for which is largely driven by the stringent re- latory requirements for purity and quality of injectable biopharmaceuticals. This is particularly reflected by the general absence of coverage of this s- ject in many biotechnology and related courses in educational institutions. For a considerable while I have felt that there is increasing need for an introductory text to various aspects of downstream processing, particularly with respect to the needs of the biopharmaceutical and biotechnology ind- try. Although there are numerous texts that cover various aspects of protein purification techniques in isolation, there is a need for a work that covers the broad range of isolation technology in an industrial setting. It is anticipated that Downstream Processing of Proteins: Methods and Protocols will play a small part in filling this gap and thus prove a useful contribution to the field. It is also designed to encourage educational strategists to broaden the coverage of these topics in industrial biotechnology courses by including accounts of this important and rapidly developing element of the industrial process.