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Biopharmaceutical Manufacturing Volume


Biopharmaceutical Manufacturing Volume
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Biopharmaceutical Manufacturing Volume


Biopharmaceutical Manufacturing Volume
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Author : Lokesh NIAZI
language : en
Publisher:
Release Date : 2021-10-31

Biopharmaceutical Manufacturing Volume written by Lokesh NIAZI and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-31 with categories.




Biopharmaceutical Manufacturing Volume


Biopharmaceutical Manufacturing Volume
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Author : Sarfaraz K. Niazi
language : en
Publisher: IOP Publishing Limited
Release Date : 2022-02-25

Biopharmaceutical Manufacturing Volume written by Sarfaraz K. Niazi and has been published by IOP Publishing Limited this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-25 with Science categories.


This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. This volume covers the unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of operation, with complete details on equipment, compliance and yield improvement suggestions. The unit processes described include several emerging trends and advice on reducing the costs of the product and efficient scale up techniques. Intended for practitioners in the commercial biopharmaceutical manufacturing industry, the text is an ideal resource for practitioners looking to develop their ability to manufacture biopharmaceutical products at a large scale. Key Features: Covers the essential aspects of commercial biopharmaceutical manufacturing for industry practitioners, including the planning, layout and operation Provides sufficient information for industry practitioners to establish and operate GMP (Good Manufacturing Practice) compliant manufacturing operations Includes case studies and step-by-step procedures for manufacturing specific biopharmaceutical products Focused exclusively on products intended for human use Includes coverage of regulatory requirements, intellectual property challenges, training of manufacturing teams and issues around cost optimisation



Biopharmaceutical Manufacturing


Biopharmaceutical Manufacturing
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Author : Sarfaraz Niazi
language : en
Publisher:
Release Date : 2022

Biopharmaceutical Manufacturing written by Sarfaraz Niazi and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022 with Pharmaceutical biotechnology categories.


This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. This volume covers the unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of operation, with complete details on equipment, compliance and yield improvement suggestions.



Biopharmaceutical Manufacturing


Biopharmaceutical Manufacturing
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Author : Sarfaraz Niazi
language : en
Publisher:
Release Date : 2021

Biopharmaceutical Manufacturing written by Sarfaraz Niazi and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with Pharmaceutical biotechnology categories.


This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide.



Single Use Technology In Biopharmaceutical Manufacture


Single Use Technology In Biopharmaceutical Manufacture
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Author : Regine Eibl
language : en
Publisher: John Wiley & Sons
Release Date : 2019-07-24

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 2019-07-24 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.



Ispe Baseline Guide Volume 6 Biopharmaceutical Manufacturing Facilities


Ispe Baseline Guide Volume 6 Biopharmaceutical Manufacturing Facilities
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Author : Ispe
language : en
Publisher:
Release Date : 2007-03

Ispe Baseline Guide Volume 6 Biopharmaceutical Manufacturing Facilities written by Ispe and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-03 with categories.




Biotechnology And Biopharmaceutical Manufacturing Processing And Preservation


Biotechnology And Biopharmaceutical Manufacturing Processing And Preservation
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Author : Kenneth E. Avis
language : en
Publisher: CRC Press
Release Date : 2020-08-13

Biotechnology And Biopharmaceutical Manufacturing Processing And Preservation written by Kenneth E. Avis and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-08-13 with Business & Economics categories.


In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.



Manufacturing Of Pharmaceutical Proteins


Manufacturing Of Pharmaceutical Proteins
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Author : Stefan Behme
language : en
Publisher: John Wiley & Sons
Release Date : 2022-04-18

Manufacturing Of Pharmaceutical Proteins written by Stefan Behme 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 2022-04-18 with Science categories.


An expert, single-volume overview of the core processes and disciplines of biopharmaceutical production In the newly revised Third Edition of Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control. Suitable as both a reference book and a training resource, this book extensively explores the impact of digital transformation on pharmaceutical protein manufacturers and includes a brand-new chapter dedicated to digitalization. The distinguished author provides readers with practical understanding of the terminology and principles driving the various fields involved with biotechnological production, including operations, legal, finance, and IT. He also offers: A thorough introduction to biopharmaceutical production, including value creation, product types, and biological basics Comprehensive explorations of the technology of the manufacturing process and analytics Practical discussions of pharmacology and drug safety, quality assurance, and pharmaceutical law In-depth examinations of pharmaceutical protein production facilities, including facility design and the planning, construction, and commissioning of a manufacturing plant Perfect for biotechnologists working in the pharmaceutical industry, Manufacturing of Pharmaceutical Proteins: From Technology to Economy will also earn a place in the libraries of pharmaceutical engineers seeking a one-stop reference for all aspects of biopharmaceutical production.



Biopharmaceutical Manufacturing


Biopharmaceutical Manufacturing
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Author : Ralf Pörtner
language : en
Publisher: Springer Nature
Release Date : 2024-02-11

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 2024-02-11 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.



Biopharmaceutical Production Technology 2 Volume Set


Biopharmaceutical Production Technology 2 Volume Set
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2012-08-20

Biopharmaceutical Production Technology 2 Volume Set 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 2012-08-20 with Medical categories.


Systematically addressing the key steps and challenges along the biopharmaceutical production process, this two volume handbook provides key knowledge for medium to large scale producers of biopharmaceuticals. The volumes are divided into six major parts, on upstream technologies, protein recovery, process development, analytical technologies, quality control, and an outlook section that addresses new and emerging technologies, such as single-use processes and integrated process design. With contributions by some 40 experts from academia, as well as small and large biopharmaceutical companies, this unique handbook is full of valuable first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.