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Author: Ganapathy Subramanian Publisher: John Wiley & Sons ISBN: 3527330291 Category : Medical Languages : en Pages : 945
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
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
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 : 367
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: Byong H. Lee Publisher: John Wiley & Sons ISBN: 1119042771 Category : Technology & Engineering Languages : en Pages : 500
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: Stefan Behme Publisher: John Wiley & Sons ISBN: 3527337660 Category : Science Languages : en Pages : 458
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: Feroz Jameel Publisher: John Wiley & Sons ISBN: 0470595876 Category : Science Languages : en Pages : 986
Book Description
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
Author: Byong H. Lee Publisher: John Wiley & Sons ISBN: 1119042763 Category : Technology & Engineering Languages : en Pages : 951
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: Wiley Publisher: John Wiley & Sons ISBN: 047017448X Category : Technology & Engineering Languages : en Pages : 1786
Book Description
This two-volume set features selected articles from the Fifth Edition of Wiley's prestigious Kirk-Othmer Encyclopedia of Chemical Technology. This compact reference features the same breadth and quality of coverage found in the original, but with a focus on topics of particular interest to food technologists, chemists, chemical and process engineers, consultants, and researchers and educators in food and agricultural businesses, alcohol and beverage industries, and related fields.
Author: Hamid Mollah Publisher: John Wiley & Sons ISBN: 0470552344 Category : Science Languages : en Pages : 432
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: Claire Komives Publisher: John Wiley & Sons ISBN: 1118361989 Category : Science Languages : en Pages : 288
Book Description
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies
Author: Ganapathy Subramanian
Author: Ganapathy Subramanian
Author: Ganapathy Subramanian
Author: Regine Eibl
Author: Byong H. Lee
Author: Stefan Behme
Author: Feroz Jameel
Author: Byong H. Lee
Author: Wiley
Author: Hamid Mollah
Author: Claire Komives