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Author: Northeast Biomanufacturing Center & Collaborative
Publisher:
ISBN: 9781939070012
Category :
Languages : en
Pages : 510
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Book Description
Today is a time of unparalleled excitement in the world of biopharmaceuticals. This book is a compendium of a tremendous body of knowledge, distilled into its most essential parts. Not only are there theoretical and conceptual ideas about biopharmaceutical manufacturing, but also content specific to skills and abilities. It serves as a well-paced guide for beginning learners as well as a cogent reference for seasoned biotechnology professionals alike. This book will help a new generation of students to become inspired and familiarize themselves with the theories, principles, and vernacular of biopharmaceutical production and all that it entails. A quick overview of contents include; Operational Excellence, Facilities, Metrology, Validation, Environmental Health & Safety (EHS), Quality Assurance, Microbiological Control, Quality Control Biochemistry, Upstream Processing, Downstream Processing, Process Development, and a Master Glossary.
Author: Northeast Biomanufacturing Center & Collaborative
Publisher:
ISBN: 9781939070012
Category :
Languages : en
Pages : 510
Get Book Here
Book Description
Today is a time of unparalleled excitement in the world of biopharmaceuticals. This book is a compendium of a tremendous body of knowledge, distilled into its most essential parts. Not only are there theoretical and conceptual ideas about biopharmaceutical manufacturing, but also content specific to skills and abilities. It serves as a well-paced guide for beginning learners as well as a cogent reference for seasoned biotechnology professionals alike. This book will help a new generation of students to become inspired and familiarize themselves with the theories, principles, and vernacular of biopharmaceutical production and all that it entails. A quick overview of contents include; Operational Excellence, Facilities, Metrology, Validation, Environmental Health & Safety (EHS), Quality Assurance, Microbiological Control, Quality Control Biochemistry, Upstream Processing, Downstream Processing, Process Development, and a Master Glossary.
Author: Jeffery Odum
Publisher: John Wiley & Sons
ISBN: 1118833651
Category : Science
Languages : en
Pages : 381
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Book Description
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
Author: Jian-Jiang Zhong
Publisher: Springer
ISBN: 9783642058097
Category : Science
Languages : en
Pages : 0
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Book Description
Advances in bioproducts manufacturing such as the production of the anticancer drug paclitaxel by large-scale plant cell culture, submerged cultivation of medicinal mushrooms, and monoclonal antibody production are reflected. Interactions among molecular, cellular and process engineering aspects in industrial fermentations are discussed, and application of fuzzy control and fuzzy neural networks to practical production and the biomedical area are shown. For sustainable development and green processing, production of lactic acid from paper sludge, production of a generic fermentation feedstock from wheat, and fabrication and application of whole-cell based biosensors in the environment are also demonstrated.
Author: Pau Loke Show
Publisher: CRC Press
ISBN: 1000407438
Category : Technology & Engineering
Languages : en
Pages : 227
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Book Description
This is the first book to present the idea of Industry 5.0 in biomanufacturing and bioprocess engineering, both upstream and downstream. The Prospect of Industry 5.0 in Biomanufacturing details the latest technologies and how they can be used efficiently and explains process analysis from an engineering point of view. In addition, it covers applications and challenges. FEATURES Describes the previous Industrial Revolution, current Industry 4.0, and how new technologies will transition toward Industry 5.0 Explains how Industry 5.0 can be applied in biomanufacturing Demonstrates new technologies catered to Industry 5.0 Uses worked examples related to biological systems This book enables readers in industry and academia working in the biomanufacturing engineering sector to understand current trends and future directions in this field.
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527340637
Category : Science
Languages : en
Pages : 628
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Book Description
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.
Author: Jian-Jiang Zhong
Publisher: Springer Science & Business Media
ISBN: 9783540205012
Category : Medical
Languages : en
Pages : 352
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Book Description
With contributions by numerous experts
Author: Chander Prakash
Publisher: Springer
ISBN: 3030139514
Category : Science
Languages : en
Pages : 279
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Book Description
Current Trends in Biomanufacturing focuses on cutting-edge research regarding the design, fabrication, assembly, and measurement of bio-elements into structures, devices, and systems. The field of biomaterial and biomanufacturing is growing exponentially in order to meet the increasing demands of for artificial joints, organs and bone-fixation devices. Rapid advances in the biological sciences and engineering are leading to newer and viable resources, methods and techniques that may providing better quality of life and more affordable health care services. The book covers the broad aspects of biomanufacturing, including: synthesis of biomaterials; implant coating techniques; spark plasma sintering; microwave processing; and cladding, powder metallurgy and electrospinning. The contributors illustrate the recent trends of biomanufacturing, highlighting the important aspects of biomaterial synthesis, and their use as feedstock of fabrication technologies and their characterization, along with their clinical practices. Current Trends in Biomanufacturing updates researchers and scientists the novelties and techniques of the field, as it summarises numerous aspects of biomanufacturing, including synthesis of biomaterials, fabrication of biomedical structures, their in-vivo/ in-vitro, mechanical analysis and associated ISO standards.
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
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: 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.
