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Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527330291
Category : Medical
Languages : en
Pages : 945
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Book Description
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.
Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527330291
Category : Medical
Languages : en
Pages : 945
Get Book Here
Book Description
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.
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: Regine Eibl
Publisher: John Wiley & Sons
ISBN: 1119477786
Category : Medical
Languages : en
Pages : 368
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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: Gunter Jagschies
Publisher: Elsevier
ISBN: 0128125527
Category : Technology & Engineering
Languages : en
Pages : 1308
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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:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
Two volumes packed with first-hand knowledge cover the key steps and challenges along the Biopharmaceutical Production process, including recent and emerging technologies such as single-use processes and integrated process design.
Author: Stefan Behme
Publisher: John Wiley & Sons
ISBN: 3527337660
Category : Science
Languages : en
Pages : 458
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Book Description
Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.
Author: Byong H. Lee
Publisher: John Wiley & Sons
ISBN: 1119042763
Category : Technology & Engineering
Languages : en
Pages : 951
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Book Description
ADVANCED FERMENTATION AND CELL TECHNOLOGY A comprehensive and up-to-date reference covering both conventional and novel industrial fermentation technologies and their applications Fermentation and cell culture technologies encompass more than the conventional microbial and enzyme systems used in the agri-food, biochemical, bioenergy and pharmaceutical industries. New technologies such as genetic engineering, systems biology, protein engineering, and mammalian cell and plant cell systems are expanding rapidly, as is the demand for sustainable production of bioingredients, drugs, bioenergy and biomaterials. As the growing biobased economy drives innovation, industrial practitioners, instructors, researchers, and students must keep pace with the development and application of novel fermentation processes and a variety of cell technologies. Advanced Fermentation and Cell Technology provides a balanced and comprehensive overview of the microbial, mammalian, and plant cell technologies used by the modern biochemical process industry to develop new and improved processes and products. This authoritative volume covers the essential features of advanced fermentation and cell technology, and highlights the interaction of food fermentation and cell culture biopharmaceutical actives. Detailed chapters, organized into five sections, cover microbial cell technology, animal and plant cell technology, safety issues of new biotechnologies, and applications of microbial fermentation to food products, chemicals, and pharmaceuticals. Written by an internationally-recognized expert in food biotechnology, this comprehensive volume: Covers both conventional and novel industrial fermentation technologies and their applications in a range of industries Discusses current progress in novel fermentation, cell culture, commercial recombinant bioproducts technologies Includes overviews of the global market size of bioproducts and the fundamentals of cell technology Highlights the importance of sustainability, Good Manufacturing Practices (GMP), quality assurance, and regulatory practices Explores microbial cell technology and culture tools and techniques such as genome shuffling and recombinant DNA technology, RNA interference and CRISPR technology, molecular thermodynamics, protein engineering, proteomics and bioinformatics, and synthetic biology Advanced Fermentation and Cell Technology is an ideal resource for students of food science, biotechnology, microbiology, agricultural sciences, biochemical engineering, and biochemistry, and is a valuable reference for food scientists, researchers, and technologists throughout the food industry, particularly the dairy, bakery, and fermented beverage sectors.
Author: Jiben Roy
Publisher: Elsevier
ISBN: 1908818042
Category : Medical
Languages : en
Pages : 449
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Book Description
This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries
Author: Hamid Mollah
Publisher: John Wiley & Sons
ISBN: 0470552344
Category : Science
Languages : en
Pages : 432
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Book Description
Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.
Author: Regine Eibl
Publisher: John Wiley & Sons
ISBN: 1119477832
Category : Medical
Languages : en
Pages : 368
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.
