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.

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.

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

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.

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.

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.

Pharmaceutical science deals with the whole spectrum of drug development from start to finish. There are many different facets to the pharmaceutical industry, from initial research to the finished product, including the equipment used, trials performed, and regulations that must be followed. Presenting an overview of all of these different aspects, the Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition is a must-have reference guide for all laboratories and libraries in the pharmaceutical field. Bringing together leaders from every specialty related to pharmaceutical science and technology, this is the single-source reference at the forefront of pharmaceutical R&D. The strength of this work is not only its breadth but also the caliber of contributing writers, all experts in their field, writing on all aspects of pharmaceutical science and technology. The fourth edition offers 29 new chapters ranging from biomarkers, computational chemistry, and contamination control to high-throughput screening, orally disintegrating tablets, and quality by design. The encyclopedia details best practices of equipment used, methods for manufacturing, options for packaging, and routes for drug delivery. The volumes also provide a thorough understanding of the choices behind each method. In addition, the regulations, safety aspects, patent guidance, and methods of analysis are presented. Key Areas Covered: Analytics Biomarkers Dosage forms Drug delivery Formulation Informatics Manufacturing Packaging Processing Regulatory affairs Systems validation This is an authoritative reference source for those practicing in any area of pharmaceutical science and technology, enabling the pharmaceutical specialist and novice alike to keep abreast of developments in this constantly evolving and highly competitive field. * Online version coming soon. Contact us to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367 / (E-mail) [email protected] International: (Tel) +44 (0) 20 7017 6062 / (E-mail) [email protected]

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

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.

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.