Download or read book ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities written by and published by . This book was released on 2013 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Engineering Guides for New and Renovated Facilities written by ISPE and published by . This book was released on 2004-06-01 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sterile Product Manufacturing Facilities written by International Society for Pharmaceutical Engineering and published by . This book was released on 2011 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Engineering Guides for New and Renovated Facilities written by and published by . This book was released on 1996 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biopharmaceutical Manufacturing Facilities written by International Society of Pharmaceutical Engineers and published by . This book was released on 2004 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book ISPE Baseline Guide Volume 3 Sterile Product Manufacturing Facilities written by Ispe and published by . This book was released on 2011-10-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Baseline Pharmaceutical Engineering Guide Sterile manufacturing facilities written by and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biopharmaceutical Manufacturing written by Gary Gilleskie and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-09-07 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:
Download or read book Baseline Pharmaceutical Engineering Guide written by and published by . This book was released on 1999 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Process Architecture in Biomanufacturing Facility Design written by Jeffery Odum and published by John Wiley & Sons. This book was released on 2018-01-26 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Risk based Manufacture of Pharmaceutical Products written by International Society for Pharmaceutical Engineering and published by . This book was released on 2010 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Process Validation in Manufacturing of Biopharmaceuticals written by Anurag Singh Rathore and published by CRC Press. This book was released on 2023-12-18 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
Download or read book ISPE Baseline Guide Volume 1 Active Pharmaceutical Ingredients written by Ispe and published by . This book was released on 2008-04-17 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book ISPE Baseline Guide Volume 7 Risk Based Manufacture of Pharmaceutical Products Risk MaPP written by Ispe and published by . This book was released on 2011-04-15 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook for Critical Cleaning Applications processes and controls written by Barbara Kanegsberg and published by CRC Press. This book was released on 2011 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nearly all companies which manufacture or fabricate high-value physical objects (components, parts, assemblies) perform critical cleaning at one or more stages. These range from the giants of the semiconductor, aerospace, and biomedical world to a host of small to medium to large companies producing a dizzying array of components"--
Download or read book Downstream Industrial Biotechnology written by Michael C. Flickinger and published by John Wiley & Sons. This book was released on 2013-07-17 with total page 884 pages. Available in PDF, EPUB and Kindle. Book excerpt: DOWNSTREAM INDUSTRIAL BIOTECHNOLOGY An affordable, easily accessible desk reference on biomanufacturing, focused on downstream recovery and purification Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be a major area of research. The downstream stage in industrial biotechnology refers to recovery, isolation, and purification of the microbial products from cell debris, processing medium and contaminating biomolecules from the upstream process into a finished product such as biopharmaceuticals and vaccines. Downstream process design has the greatest impact on overall biomanufacturing cost because not only does the biochemistry of different products ( e.g., peptides, proteins, hormones, antibiotics, and complex antigens) dictate different methods for the isolation and purification of these products, but contaminating byproducts can also reduce overall process yield, and may have serious consequences on clinical safety and efficacy. Therefore downstream separation scientists and engineers are continually seeking to eliminate, or combine, unit operations to minimize the number of process steps in order to maximize product recovery at a specified concentration and purity. Based on Wiley’s Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this volume features fifty articles that provide information on down- stream recovery of cells and protein capture; process development and facility design; equipment; PAT in downstream processes; downstream cGMP operations; and regulatory compliance. It covers: Cell wall disruption and lysis Cell recovery by centrifugation and filtration Large-scale protein chromatography Scale down of biopharmaceutical purification operations Lipopolysaccharide removal Porous media in biotechnology Equipment used in industrial protein purification Affinity chromatography Antibody purification, monoclonal and polyclonal Protein aggregation, precipitation and crystallization Freeze-drying of biopharmaceuticals Biopharmaceutical facility design and validation Pharmaceutical bioburden testing Regulatory requirements Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Downstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries.
Download or read book Biopharmaceutical Processing written by Gunter Jagschies and published by Elsevier. This book was released on 2018-01-18 with total page 1310 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
