Advanced Technologies In Biopharmaceutical Processing
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Advanced Technologies In Biopharmaceutical Processing
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Author : Roshni Dutton
language : en
Publisher: Wiley-Blackwell
Release Date : 2006-10-30
Advanced Technologies In Biopharmaceutical Processing written by Roshni Dutton and has been published by Wiley-Blackwell this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-10-30 with Science categories.
An increasing number of pharmaceuticals in human and veterinary medicine are being developed using advanced genetic and other methods that focus on modification of somatic and embryonic cells. These methods, in the setting of drug manufacture, call for new processes that go beyond the traditional unit processes of chemical and biological production, such as batch submerged culture. This book is the first to describe in detail these advanced biological processes and show how they are applied to the production of biopharmaceuticals, from product generation and purification to fill-finish operations. The work explains how technologies developed in the last decade function similarly to unit operations for producing advanced biopharmaceuticals, such as hormones, cytokines, therapeutic enzymes, modified proteins, and transgenic products - to name a few. From large-scale animal cell bioreactors to patient-customized products, this volume describes the effects of new technologies on biopharmaceutical processes and guides users on how to apply new technologies in process development.
Single Use Technology In Biopharmaceutical Manufacture
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Author : Regine Eibl
language : en
Publisher: John Wiley & Sons
Release Date : 2019-08-27
Single Use Technology In Biopharmaceutical Manufacture written by Regine Eibl and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-27 with Medical categories.
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 And Purification In The Biopharmaceutical Industry
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Author : Maik W. Jornitz
language : en
Publisher:
Release Date : 2019
Filtration And Purification In The Biopharmaceutical Industry written by Maik W. Jornitz and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with Biological products categories.
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 this field including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. An essential, comprehensive source for all professionals involved with filtration and purification practices and compliance, this text describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and buffer filtration.
Biopharmaceutical Production Technology
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2012-05-14
Biopharmaceutical Production Technology written by Ganapathy Subramanian and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-14 with Medical categories.
Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.
Bioprocessing Technology For Production Of Biopharmaceuticals And Bioproducts
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Author : Claire Komives
language : en
Publisher: John Wiley & Sons
Release Date : 2018-12-27
Bioprocessing Technology For Production Of Biopharmaceuticals And Bioproducts written by Claire Komives and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-27 with Science categories.
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies
Filtration And Purification In The Biopharmaceutical Industry Third Edition
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Author : Maik W. Jornitz
language : en
Publisher: CRC Press
Release Date : 2019-06-26
Filtration And Purification In The Biopharmaceutical Industry Third Edition written by Maik W. Jornitz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-26 with Business & Economics categories.
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.
Filtration And Purification In The Biopharmaceutical Industry Second Edition
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Author : Maik J. Jornitz
language : en
Publisher: CRC Press
Release Date : 2007-11-28
Filtration And Purification In The Biopharmaceutical Industry Second Edition written by Maik J. Jornitz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-28 with Medical categories.
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, including the current methods, processes, technologies and equipment, and brings you up-to-date with the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. An essential, comprehensive, source for all professionals involved with filtration and purification practices and compliance, this text · addresses recent biotechnology-related processes and advanced technologies, such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and medium and buffer filtration · presents detailed updates on the latest FDA and EMEA regulatory requirements involving filtration and purification practices · describes current industry quality standards and validation requirements and provides guidance for compliance Audience:
Biopharmaceutical Processing
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Author : Gunter Jagschies
language : en
Publisher: Elsevier
Release Date : 2018-01-18
Biopharmaceutical Processing written by Gunter Jagschies and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-18 with Technology & Engineering categories.
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference
Pat Applied In Biopharmaceutical Process Development And Manufacturing
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Author : Cenk Undey
language : en
Publisher: CRC Press
Release Date : 2011-12-07
Pat Applied In Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-07 with Medical categories.
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Process Control Intensification And Digitalisation In Continuous Biomanufacturing
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2021-12-15
Process Control Intensification And Digitalisation In Continuous Biomanufacturing written by Ganapathy Subramanian and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-15 with Technology & Engineering categories.
Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the ??technology, the last decade has demonstrated the utility of continuous ??processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor’s Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing.