Filtration And Purification In The Biopharmaceutical Industry PDF Download
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| Author | : Maik J. Jornitz |
| Publisher | : CRC Press |
| Total Pages | : 816 |
| Release | : 2007-11-28 |
| Genre | : Medical |
| ISBN | : 0849379547 |
Download Filtration and Purification in the Biopharmaceutical Industry Book in PDF, ePub and Kindle
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 | : Maik W. Jornitz |
| Publisher | : CRC Press |
| Total Pages | : 673 |
| Release | : 2019-06-26 |
| Genre | : Business & Economics |
| ISBN | : 1351675699 |
Download Filtration and Purification in the Biopharmaceutical Industry, Third Edition Book in PDF, ePub and Kindle
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 | : Theodore H. Meltzer |
| Publisher | : CRC Press |
| Total Pages | : 950 |
| Release | : 1998-01-05 |
| Genre | : Medical |
| ISBN | : 9780824798963 |
Download Filtration in the Biopharmaceutical Industry Book in PDF, ePub and Kindle
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 | : Abhinav A. Shukla |
| Publisher | : CRC Press |
| Total Pages | : 600 |
| Release | : 2006-07-07 |
| Genre | : Medical |
| ISBN | : 1420016024 |
Download Process Scale Bioseparations for the Biopharmaceutical Industry Book in PDF, ePub and Kindle
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 | : Maik W. Jornitz |
| Publisher | : CRC Press |
| Total Pages | : 640 |
| Release | : 2020-04-15 |
| Genre | : Business & Economics |
| ISBN | : 1420030094 |
Download Sterile Filtration Book in PDF, ePub and Kindle
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 | : Allan Matte |
| Publisher | : Elsevier |
| Total Pages | : 222 |
| Release | : 2020-09-07 |
| Genre | : Business & Economics |
| ISBN | : 0081030193 |
Download Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics Book in PDF, ePub and Kindle
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 | : Regine Eibl |
| Publisher | : John Wiley & Sons |
| Total Pages | : 672 |
| Release | : 2019-07-24 |
| Genre | : Medical |
| ISBN | : 1119477778 |
Download Single-Use Technology in Biopharmaceutical Manufacture Book in PDF, ePub and Kindle
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 | : Mohamed A. Desai |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 233 |
| Release | : 2008-02-05 |
| Genre | : Science |
| ISBN | : 1592590276 |
Download Downstream Processing of Proteins Book in PDF, ePub and Kindle
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.
| Author | : Gary Gilleskie |
| Publisher | : Walter de Gruyter GmbH & Co KG |
| Total Pages | : 433 |
| Release | : 2021-09-07 |
| Genre | : Science |
| ISBN | : 3110617013 |
Download Biopharmaceutical Manufacturing Book in PDF, ePub and Kindle
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:
| Author | : Herb Lutz |
| Publisher | : Elsevier |
| Total Pages | : 245 |
| Release | : 2015-02-17 |
| Genre | : Science |
| ISBN | : 1908818530 |
Download Ultrafiltration for Bioprocessing Book in PDF, ePub and Kindle
Ultrafiltration for Bioprocessing is key reading for all those involved in the biotechnology and biopharmaceutical areas. Written by a leading worker in the area, it includes many practical applications and case studies in the key process of ultrafiltration (UF), which is used in almost every bioprocess. Focuses on ultrafiltration for biopharmaceuticals—other books look at general ultrafiltration or general biopharmaceuticals A mix of theory and practical applications—other books tend to be more theory-oriented Addresses the main issues encountered in development and scale-up through recommendations and case studies
