Author: Maik J. Jornitz
Publisher: CRC Press
ISBN: 0849379547
Category : Medical
Languages : en
Pages : 816
Get Book Here
Book Description
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: 9780824798963
Category : Medical
Languages : en
Pages : 950
Get Book Here
Book Description
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: 1351675699
Category : Business & Economics
Languages : en
Pages : 673
Get Book Here
Book Description
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: Abhinav A. Shukla
Publisher: CRC Press
ISBN: 1420016024
Category : Medical
Languages : en
Pages : 600
Get Book Here
Book Description
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
ISBN: 1420030094
Category : Business & Economics
Languages : en
Pages : 640
Get Book Here
Book Description
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: Regine Eibl
Publisher: John Wiley & Sons
ISBN: 1119477786
Category : Medical
Languages : en
Pages : 368
Get Book Here
Book Description
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: Theodore H. Meltzer
Publisher: CRC Press
ISBN: 9780824775193
Category : Medical
Languages : en
Pages : 1120
Get Book Here
Book Description
Author: Allan Matte
Publisher: Elsevier
ISBN: 0081030193
Category : Business & Economics
Languages : en
Pages : 222
Get Book Here
Book Description
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: Gary Gilleskie
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110617013
Category : Science
Languages : en
Pages : 433
Get Book Here
Book Description
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: Adam P. Fraise
Publisher: John Wiley & Sons
ISBN: 0470755067
Category : Medical
Languages : en
Pages : 691
Get Book Here
Book Description
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
