Practical Guide To Single Use Technology

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Practical Guide To Single Use Technology

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Author : Adriana G Lopes
language : en
Publisher: Smithers Rapra
Release Date : 2016-08-31

Practical Guide To Single Use Technology written by Adriana G Lopes and has been published by Smithers Rapra this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-31 with Science categories.

Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements.Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents:An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems;SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP;Strategy for standardisation of single-use bag systems and assessment of extractables and leachables;Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams;Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; andQualification approach for different SUT types.With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT.

Single Use Technology

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Author : Adriana G. Lopes
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2019-06-17

Single Use Technology written by Adriana G. Lopes and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-17 with Science categories.

Single-Use Technology (SUT) is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Having become readily available for all processing operations within the biopharmaceutical industry, SUT has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types.

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.

Practical Guide To Single Use Technology

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Author : Adriana G. Lopes
language : en
Publisher:
Release Date : 2016

Practical Guide To Single Use Technology written by Adriana G. Lopes and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with Medical supplies, Disposable categories.

Single Use Technology

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Author : Adriana G. Lopes
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2019-06-17

Single Use Technology written by Adriana G. Lopes and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-17 with Science categories.

Single-Use Technology (SUT) is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Having become readily available for all processing operations within the biopharmaceutical industry, SUT has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types.

Handbook Of Validation In Pharmaceutical Processes Fourth Edition

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Author : James Agalloco
language : en
Publisher: CRC Press
Release Date : 2021-10-28

Handbook Of Validation In Pharmaceutical Processes Fourth Edition written by James Agalloco and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-28 with Medical categories.

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

A Practical Guide For Medical Teachers

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Author : John Dent
language : en
Publisher: Elsevier Health Sciences
Release Date : 2017-04-26

A Practical Guide For Medical Teachers written by John Dent and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-26 with Medical categories.

The Fifth Edition of the highly praised Practical Guide for Medical Teachers provides a bridge between the theoretical aspects of medical education and the delivery of enthusiastic and effective teaching in basic science and clinical medicine. Healthcare professionals are committed teachers and this book is an essential guide to help them maximise their performance. - This highly regarded book recognises the importance of educational skills in the delivery of quality teaching in medicine. - The contents offer valuable insights into all important aspects of medical education today. - A leading educationalist from the USA joins the book's editorial team. - The continual emergence of new topics is recognised in this new edition with nine new chapters: The role of patients as teachers and assessors; Medical humanities; Decision-making; Alternative medicine; Global awareness; Education at a time of ubiquitous information; Programmative assessment; Student engagement; and Social accountability. - An enlarged group of authors from more than 15 countries provides both an international perspective and a multi-professional approach to topics of interest to all healthcare teachers.

Gmp Audits In Pharmaceutical And Biotechnology Industries

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Author : Mustafa Edik
language : en
Publisher: CRC Press
Release Date : 2024-06-28

Gmp Audits In Pharmaceutical And Biotechnology Industries written by Mustafa Edik and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-06-28 with Medical categories.

The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.

Biofabrication

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Author : Aurelien Forget
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2022-12-05

Biofabrication written by Aurelien Forget and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-05 with Technology & Engineering categories.

The term biofabrication is defined as the automated generation of biologically functional products with structural organization. Combining cells with biomaterials, biofabrication consists of using industrial methods to combine cells with biomaterials. This book covers the different strategies and established techniques to create artificial living tissues. By providing an overview of the whole biofabrication development process, including design phase, manufacturing, and evaluation of the resulting product it is the perfect support for the classroom. This book enables students to jump into the field of biofabrication by covering all the aspects of this highly active field of science at the intersection of cell biology, molecular biology, engineering, materials science, and chemistry.

Biopharmaceutical Manufacturing

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Author : Ralf Pörtner
language : en
Publisher: Springer Nature
Release Date : 2024-01-10

Biopharmaceutical Manufacturing written by Ralf Pörtner and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-01-10 with Science categories.

This volume “Cell Engineerring 11 - Biopharmaceutical Manufacturing: Progress, Trends and Challenges” is a source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation. The book comprises contributions of experts from academia and industry active in the field of cell culture development for the production of recombinant proteins, cell therapy and gene therapy, with consideration of Digital Twin ́s and facility design. The knowledge and expertise of the authors cover disciplines like cell biology, engineering, biotechnology and biomedical sciences. Inevitably, some omissions will occur in the test, but the authors have sought to avoid duplications by extensive cross-referencing to chapters in other volumes of this series and elsewhere. We hope the volume provides a useful compendium of techniques for scientists in industrial and research laboratories active in this field.