Single-Use Technology in Biopharmaceutical Manufacture PDF Download
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Author: Regine Eibl
Publisher: John Wiley & Sons
ISBN: 1119477786
Category : Medical
Languages : en
Pages : 367
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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: Regine Eibl
Publisher: John Wiley & Sons
ISBN: 1119477786
Category : Medical
Languages : en
Pages : 367
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: Ispe
Publisher:
ISBN: 9781946964120
Category :
Languages : en
Pages : 176
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Book Description
Author: Gunter Jagschies
Publisher: Elsevier
ISBN: 0128125527
Category : Technology & Engineering
Languages : en
Pages : 1310
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Book Description
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
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527653112
Category : Medical
Languages : en
Pages : 945
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Book Description
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.
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527347690
Category : Technology & Engineering
Languages : en
Pages : 404
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Book Description
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.
Author: Markus Schönberger
Publisher: William Andrew
ISBN: 0323374654
Category : Technology & Engineering
Languages : en
Pages : 304
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Book Description
Emerging Trends in Medical Plastic Engineering and Manufacturing gives engineers and materials scientists working in the field detailed insights into upcoming technologies in medical polymers. While plastic manufacturing combines the possibility of mass production and wide design variability, there are still opportunities within the plastic engineering field which have not been fully adopted in the medical industry. In addition, there are numerous additional challenges related to the development of products for this industry, such as ensuring tolerance to disinfection, biocompatibility, selecting compliant additives for processing, and more. This book enables product designers, polymer processing engineers, and manufacturing engineers to take advantage of the numerous upcoming developments in medical plastics, such as autoregulated volume-correction to achieve zero defect production or the development of 'intelligent' single use plastic products, and methods for sterile manufacturing which reduce the need for subsequent sterilization processes. Finally, as medical devices get smaller, the book discusses the challenges posed by miniaturization for injection molders, how to respond to these challenges, and the rapidly advancing prototyping technologies. - Provides a roadmap to the emerging technologies for polymers in the medical device industry, including coverage of 'intelligent' single use products, personalized medical devices, and the integration of manufacturing steps to improve workflows - Helps engineers in the biomedical and medical devices industries to navigate and anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, and government regulations - Presents tactics readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce defects in production and develop products that enable entirely new treatment possibilities
Author: Sudhir P. Singh
Publisher: John Wiley & Sons
ISBN: 1119717248
Category : Science
Languages : en
Pages : 452
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Book Description
Discover a comprehensive and current overview of microbial bioprospecting written by leading voices in the field In Bioprospecting of Microorganism-Based Industrial Molecules, distinguished researchers and authors Sudhir P. Singh and Santosh Kumar Upadhyay deliver global perspectives of bioprospecting of biodiversity. The book covers diverse aspects of bioprospecting of microorganisms demonstrating biomass value of nutraceutical, pharmaceutical, biomedical, and bioenergetic importance. The authors present an amalgamation of translational research on bioresource utilization and ecological sustainability that will further the reader’s knowledge of the applications of different microbial diversity and reveal new avenues of research investigation. Readers will also benefit from: A thorough introduction to microbial biodiversity and bioprospecting An exploration of anti-ageing and skin lightening microbial products and microbial production of anti-cancerous biomolecules A treatment of UV protective compounds from algal biodiversity and polysaccharides from marine microalgal sources Discussions of microbial sources of insect toxic proteins and the role of microbes in bio-surfactants production Perfect for academics, scientists, researchers, graduate and post-graduate students working and studying in the areas of microbiology, food biotechnology, industrial microbiology, plant biotechnology, and microbial biotechnology, Bioprospecting of Microorganism-Based Industrial Molecules is an indispensable guide for anyone looking for a comprehensive overview of the subject.
Author: Joaquim M.S. Cabral
Publisher: Elsevier
ISBN: 0444632662
Category : Medical
Languages : en
Pages : 342
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Book Description
Stem Cell Manufacturing discusses the required technologies that enable the transfer of the current laboratory-based practice of stem cell tissue culture to the clinic environment as therapeutics, while concurrently achieving control, reproducibility, automation, validation, and safety of the process and the product. The advent of stem cell research unveiled the therapeutic potential of stem cells and their derivatives and increased the awareness of the public and scientific community for the topic. The successful manufacturing of stem cells and their derivatives is expected to have a positive impact in the society since it will contribute to widen the offer of therapeutic solutions to the patients. Fully defined cellular products can be used to restore the structure and function of damaged tissues and organs and to develop stem cell-based cellular therapies for the treatment of cancer and hematological disorders, autoimmune and other inflammatory diseases and genetic disorders. - Presents the first 'Flowchart' of stem cell manufacturing enabling easy understanding of the various processes in a sequential and coherent manner - Covers all bioprocess technologies required for the transfer of the bench findings to the clinic including the process components: cell signals, bioreactors, modeling, automation, safety, etc. - Presents comprehensive coverage of a true multidisciplinary topic by bringing together specialists in their particular area - Provides the basics of the processes and identifies the issues to be resolved for large scale cell culture by the bioengineer - Addresses the critical need in bioprocessing for the successful delivery of stem cell technology to the market place by involving professional engineers in sections of the book
Author: Maik W. Jornitz
Publisher: CRC Press
ISBN: 1351675699
Category : Business & Economics
Languages : en
Pages : 673
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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: Nigel J Smart
Publisher: Elsevier
ISBN: 1908818409
Category : Science
Languages : en
Pages : 384
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Book Description
With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. - A focus on the issues associated with the application of lean principles to biomanufacturing - Practical examples of factors which can affect biopharmaceutical processes - Coverage of key factors which require integration to run an efficient biopharmaceutical process
