Downstream Industrial Biotechnology: Recovery and Purification

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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, biophar- maceutical 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.

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About the author

Dr. Michael C. Flickinger is Associate Director for Academic Programs of the Golden LEAF Biomanufacturing Training and Education Center (BTEC) and a Professor of Chemical and Biomolecular Engineering at North Carolina State University, Raleigh.

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Additional Information

Publisher
John Wiley & Sons
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Published on
Jul 17, 2013
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Pages
872
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ISBN
9781118618981
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Language
English
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Genres
Science / Biotechnology
Science / Chemistry / General
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Content Protection
This content is DRM protected.
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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 regionsFocuses 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 agenciesIncludes 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.

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