Viral Clearance For Continuous Biopharmaceutical Processes
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Viral Clearance For Continuous Biopharmaceutical Processes
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Author : Laura David
language : en
Publisher:
Release Date : 2020
Viral Clearance For Continuous Biopharmaceutical Processes written by Laura David and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with categories.
Continuous Manufacturing For The Modernization Of Pharmaceutical Production
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2019-03-05
Continuous Manufacturing For The Modernization Of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-05 with Medical categories.
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Continuous Biopharmaceutical Processes
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Author : David Pfister
language : en
Publisher: Cambridge University Press
Release Date : 2018-10-11
Continuous Biopharmaceutical Processes written by David Pfister and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-11 with Medical categories.
Provides a coherent and critical view on the potential benefits of various continuous processes in the biopharmaceutical industry.
Continuous Processing In Pharmaceutical Manufacturing
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2015-02-09
Continuous Processing In Pharmaceutical Manufacturing 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 2015-02-09 with Medical categories.
With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.
Process Validation In Manufacturing Of Biopharmaceuticals
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Author : Anurag Singh Rathore
language : en
Publisher: CRC Press
Release Date : 2023-12-18
Process Validation In Manufacturing Of Biopharmaceuticals written by Anurag Singh Rathore and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-18 with Medical categories.
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
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.
Single Use Technology In Biopharmaceutical Manufacture
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Author : Regine Eibl
language : en
Publisher: John Wiley & Sons
Release Date : 2019-07-18
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 2019-07-18 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.
A Guide To Viral Clearance
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Author : Hazel Aranha
language : en
Publisher:
Release Date : 2004
A Guide To Viral Clearance written by Hazel Aranha and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Pharmaceutical biotechnology categories.
Continuous Biomanufacturing
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2017-09-12
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 2017-09-12 with Science categories.
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.
Viral Safety And Evaluation Of Viral Clearance From Biopharmaceutical Products
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Author : Fred Brown
language : en
Publisher: S. Karger AG (Switzerland)
Release Date : 1996
Viral Safety And Evaluation Of Viral Clearance From Biopharmaceutical Products written by Fred Brown and has been published by S. Karger AG (Switzerland) this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996 with Medical categories.
Assurance that biopharmaceuticals do not contain unwanted infectious agents is a vital safety consideration in the use of these products. This can only be ensured by careful screening of the cells and other materials used in their production, and subsequent testing of the final product. This publication reports the proceedings of an international conference which focused on the methods of how to avoid contamination of cell cultures with virus during the production process of biologicals, with the aim of providing harmonized guidelines to ensure product safety. Scientists from industry and regulatory agencies present updates on the current state of knowledge about assays for viral contamination and procedures for inactivation and removal. Risks associated with the processing of biopharmaceuticals are identified, and data on the actual experiences of testing and industrial laboratories are presented and discussed in the context of the clinical setting. Drawing together a wealth of new data, this book will be essential reading for all scientists concerned with the development, production and quality control of biopharmaceutical products.