Single Use Technology

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Single-Use Technology in Biopharmaceutical Manufacture

Regine Eibl,Dieter Eibl
Single Use Technology in Biopharmaceutical Manufacture Book PDF

Author : Regine Eibl,Dieter Eibl
Publisher : John Wiley & Sons
Page : 672 pages
File Size : 47,9 Mb
Release : 2019-07-24
Category : Medical
ISBN : 9781119477778

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Single-Use Technology in Biopharmaceutical Manufacture by Regine Eibl,Dieter Eibl Pdf

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.

Biopharmaceutical Processing

Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
Biopharmaceutical Processing Book PDF

Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
Publisher : Elsevier
Page : 1308 pages
File Size : 53,7 Mb
Release : 2018-01-18
Category : Technology & Engineering
ISBN : 9780128125526

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Biopharmaceutical Processing by Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher Pdf

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

Disposable Bioreactors II

Dieter Eibl,Regine Eibl
Disposable Bioreactors II Book PDF

Author : Dieter Eibl,Regine Eibl
Publisher : Springer
Page : 296 pages
File Size : 50,7 Mb
Release : 2013-12-17
Category : Science
ISBN : 9783642451584

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Disposable Bioreactors II by Dieter Eibl,Regine Eibl Pdf

Dynamic Single-Use Bioreactors Used in Modern Liter- and m3- Scale Biotechnological Processes: Engineering Characteristics and Scaling Up, by Christian Löffelholz, Stephan C. Kaiser, Matthias Kraume, Regine Eibl , Dieter Eibl. Orbitally Shaken Single-Use Bioreactors, by Wolf Klöckner, Sylvia Diederichs, Jochen Büchs. Therapeutic Human Cells: Manufacture for Cell Therapy/Regenerative Medicine by Christian van den Bos, Robert Keefe, Carmen Schirmaier, Michael McCaman. Fast Single-Use VLP Vaccine Productions Based on Insect Cells and the Baculovirus Expression Vector System: Influenza as Case Study by Regine Eibl, Nina Steiger, Sabine Wellnitz, Tiago Vicente, Corinne John, Dieter Eibl. Microbial High Cell Density Fermentations in a Stirred Single-Use Bioreactor by Thomas Dreher, Bart Walcarius, Ute Husemann, Franziska Klingenberg, Christian Zahnow, Thorsten Adams, Davy de Wilde, Peter Casteels, Gerhard Greller. Quorus Bioreactor: A New Perfusion-Based Technology for Microbial Cultivation by Sheena J. Fraser, Christian Endres. Cultivation of Marine Microorganisms in Single-Use Systems by Friederike Hillig, Maciej Pilarek, Stefan Junne, Peter Neubauer. Flexible Biomanufacturing Processes that Address the Needs of the Future by Bernhard Diel, Christian Manzke, Thorsten Peuker. An Approach to Quality and Security of Supply for Single-Use Bioreactors by Magali Barbaroux, Susanne Gerighausen, Heiko Hackel. A Risk Analysis for Production Processes with Disposable Bioreactors by Tobias Merseburger, Ina Pahl, Daniel Müller, Markus Tanner.

Single-Use Technology

Adriana G. Lopes,Andrew Brown
Single Use Technology Book PDF

Author : Adriana G. Lopes,Andrew Brown
Publisher : Walter de Gruyter GmbH & Co KG
Page : 174 pages
File Size : 48,7 Mb
Release : 2019-06-17
Category : Science
ISBN : 9783110640670

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Single-Use Technology by Adriana G. Lopes,Andrew Brown Pdf

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

Regine Eibl,Dieter Eibl
Single Use Technology in Biopharmaceutical Manufacture Book PDF

Author : Regine Eibl,Dieter Eibl
Publisher : John Wiley & Sons
Page : 368 pages
File Size : 46,5 Mb
Release : 2019-08-27
Category : Medical
ISBN : 9781119477839

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Single-Use Technology in Biopharmaceutical Manufacture by Regine Eibl,Dieter Eibl Pdf

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.

Continuous Processing in Pharmaceutical Manufacturing

Ganapathy Subramanian
Continuous Processing in Pharmaceutical Manufacturing Book PDF

Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Page : 528 pages
File Size : 44,9 Mb
Release : 2015-02-09
Category : Medical
ISBN : 9783527335954

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Continuous Processing in Pharmaceutical Manufacturing by Ganapathy Subramanian Pdf

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.

Biopharmaceutical Production Technology

Ganapathy Subramanian
Biopharmaceutical Production Technology Book PDF

Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Page : 945 pages
File Size : 40,6 Mb
Release : 2012-05-14
Category : Medical
ISBN : 9783527653119

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Biopharmaceutical Production Technology by Ganapathy Subramanian Pdf

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.

Practical Guide to Single-use Technology

Adriana G Lopes
Practical Guide to Single use Technology Book PDF

Author : Adriana G Lopes
Publisher : Smithers Rapra
Page : 178 pages
File Size : 41,9 Mb
Release : 2016-08-31
Category : Science
ISBN : 9781910242049

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Practical Guide to Single-use Technology by Adriana G Lopes Pdf

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.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology
Continuous Manufacturing for the Modernization of Pharmaceutical Production Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology
Publisher : National Academies Press
Page : 69 pages
File Size : 44,6 Mb
Release : 2019-04-05
Category : Medical
ISBN : 9780309487818

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Continuous Manufacturing for the Modernization of Pharmaceutical Production by National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology Pdf

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.

The Fourth Industrial Revolution

Klaus Schwab
The Fourth Industrial Revolution Book PDF

Author : Klaus Schwab
Publisher : Currency
Page : 192 pages
File Size : 51,7 Mb
Release : 2017-01-03
Category : Business & Economics
ISBN : 9781524758875

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The Fourth Industrial Revolution by Klaus Schwab Pdf

World-renowned economist Klaus Schwab, Founder and Executive Chairman of the World Economic Forum, explains that we have an opportunity to shape the fourth industrial revolu­tion, which will fundamentally alter how we live and work. Schwab argues that this revolution is different in scale, scope and complexity from any that have come before. Characterized by a range of new technologies that are fusing the physical, digital and biological worlds, the developments are affecting all disciplines, economies, industries and governments, and even challenging ideas about what it means to be human. Artificial intelligence is already all around us, from supercomputers, drones and virtual assistants to 3D printing, DNA sequencing, smart thermostats, wear­able sensors and microchips smaller than a grain of sand. But this is just the beginning: nanomaterials 200 times stronger than steel and a million times thinner than a strand of hair and the first transplant of a 3D printed liver are already in development. Imagine “smart factories” in which global systems of manu­facturing are coordinated virtually, or implantable mobile phones made of biosynthetic materials. The fourth industrial revolution, says Schwab, is more significant, and its ramifications more profound, than in any prior period of human history. He outlines the key technologies driving this revolution and discusses the major impacts expected on government, business, civil society and individu­als. Schwab also offers bold ideas on how to harness these changes and shape a better future—one in which technology empowers people rather than replaces them; progress serves society rather than disrupts it; and in which innovators respect moral and ethical boundaries rather than cross them. We all have the opportunity to contribute to developing new frame­works that advance progress.

Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables

Suzanne Culleton
Disposable Technology and Single Use Systems Regulatory Perspective Best Practices and Future Trends of Extractables and Leachables Book PDF

Author : Suzanne Culleton
Publisher : GRIN Verlag
Page : 57 pages
File Size : 46,7 Mb
Release : 2019-11-14
Category : Medical
ISBN : 9783346064783

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Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables by Suzanne Culleton Pdf

Master's Thesis from the year 2015 in the subject Medicine - Biomedical Engineering, grade: 1.1, , course: MSc. Industrial Pharmaceutical Science, language: English, abstract: With the adoption of Disposable and Single-use manufacturing equipment on the rise, it is logical there is an industry push to develop a standardised set of testing requirements to thoroughly evaluate the impact of extractable and leachable (E&L) contaminants on patient safety. The main objectives of this work are to critically evaluate the preliminary research previously undertaken on the subject area of Single-Use Systems (SUS) with emphasis on the data currently generated from vendors of single-use systems, the need for harmonised supplier data, current methodologies and best practices employed for E&L testing, and also identification of key areas that warrant further study. This will be accomplished using both quantitative and qualitative research methods where primary data is sourced directly from interviews with experienced professionals in the field. The secondary information is obtained from the critical analysis of scientific publications, scholarly articles, databases, and use of statistical data generated from recent surveys on the challenges E&L present and how industry have addressed this matter thus far. From an extractables and leachables viewpoint the regulatory outlook is still quite uncertain. Some SUS suppliers deliver a very strong data package which satisfies the needs of the drug product manufacturer while others fail in this regard. So, in that sense the evaluation of extractables and leachables remains a grey area at present. The challenge for the industry now is to achieve uniformity of data across multiple single-use vendors to facilitate end user risk assessment and compliance for future regulatory submissions and better patient care.

Single-Use Technology

Adriana G. Lopes,Andrew Brown
Single Use Technology Book PDF

Author : Adriana G. Lopes,Andrew Brown
Publisher : Walter de Gruyter GmbH & Co KG
Page : 154 pages
File Size : 47,9 Mb
Release : 2019-06-17
Category : Science
ISBN : 9783110640588

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Single-Use Technology by Adriana G. Lopes,Andrew Brown Pdf

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.

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics

Allan Matte
Approaches to the Purification Analysis and Characterization of Antibody Based Therapeutics Book PDF

Author : Allan Matte
Publisher : Elsevier
Page : 222 pages
File Size : 43,7 Mb
Release : 2020-09-07
Category : Business & Economics
ISBN : 9780081030196

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Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics by Allan Matte Pdf

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

Alone Together

Sherry Turkle
Alone Together Book PDF

Author : Sherry Turkle
Publisher : Basic Books
Page : 400 pages
File Size : 50,7 Mb
Release : 2017-11-07
Category : Psychology
ISBN : 9780465093663

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Alone Together by Sherry Turkle Pdf

"Savvy and insightful." --New York Times Technology has become the architect of our intimacies. Online, we fall prey to the illusion of companionship, gathering thousands of Twitter and Facebook friends, and confusing tweets and wall posts with authentic communication. But this relentless connection leads to a deep solitude. MIT professor Sherry Turkle argues that as technology ramps up, our emotional lives ramp down. Based on hundreds of interviews and with a new introduction taking us to the present day, Alone Together describes changing, unsettling relationships between friends, lovers, and families.

iGen

Jean M. Twenge
iGen Book PDF

Author : Jean M. Twenge
Publisher : Simon and Schuster
Page : 452 pages
File Size : 47,6 Mb
Release : 2017-08-22
Category : Social Science
ISBN : 9781501152023

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iGen by Jean M. Twenge Pdf

As seen in Time, USA TODAY, The Atlantic, The Wall Street Journal, and on CBS This Morning, BBC, PBS, CNN, and NPR, iGen is crucial reading to understand how the children, teens, and young adults born in the mid-1990s and later are vastly different from their Millennial predecessors, and from any other generation. With generational divides wider than ever, parents, educators, and employers have an urgent need to understand today’s rising generation of teens and young adults. Born in the mid-1990s up to the mid-2000s, iGen is the first generation to spend their entire adolescence in the age of the smartphone. With social media and texting replacing other activities, iGen spends less time with their friends in person—perhaps contributing to their unprecedented levels of anxiety, depression, and loneliness. But technology is not the only thing that makes iGen distinct from every generation before them; they are also different in how they spend their time, how they behave, and in their attitudes toward religion, sexuality, and politics. They socialize in completely new ways, reject once sacred social taboos, and want different things from their lives and careers. More than previous generations, they are obsessed with safety, focused on tolerance, and have no patience for inequality. With the first members of iGen just graduating from college, we all need to understand them: friends and family need to look out for them; businesses must figure out how to recruit them and sell to them; colleges and universities must know how to educate and guide them. And members of iGen also need to understand themselves as they communicate with their elders and explain their views to their older peers. Because where iGen goes, so goes our nation—and the world.