1st Edition

Producing Biomolecular Substances with Fermenters, Bioreactors, and Biomolecular Synthesizers

By William L. Hochfeld Copyright 2006
    406 Pages 61 B/W Illustrations
    by CRC Press

    Containing authoritative and in-depth coverage, Producing Biomolecular Materials Using Fermenters, Bioreactors, and Biomolecular Synthesizers examines the bioproduction systems that support the controlled, automated, and quantity growth of proteins. The book discusses the substance, character, makeup, and quality of the basic materials used in the production and downstream processing of boimolecular materials: raw materials, reagents, intermediates, and consumables.

    Dr. Hochfield gets right to the point, explaining just what must be done and how to do it effectively, then providing the formula necessary for reaching the required value, allowing you to simply plug-in your data and make protein. However, if you actually do need the origin and derivation of any given formula, you can go right to the extensive reference section in the Appendix, find the formula you need in the exact form that you need it, without having to wade through numerous pages of extraneous material.

    This classic work presents unparalled, detailed, and cutting-edge information on bioprocessing systems. A working reference and formulary for producing recombinant, bioactive, or other exotic proteins, peptides, and nucleic acids to specification, the text provides coverage of the related technologies, coupled with the extensive biotechnology glossary, manufacturer’s directories, extensive references, important formulae, charts, illustrations, comprehensive index, emphasis on practical techniques, time-proven methods, and essential applications. These features combine with its ingenious, easy-to-use layout to make it the resource you will consult on a regular basis.

    Introduction


    Biotechnology
    Bioproduction
    The Bioprocess
    Cell Lines
    Cell-Culture Process
    Separation, Recovery, Purification
    Virus and Foreign-DNA Removal
    Quality Assurance
    Technology Overview
    Biomolecular Foundations
    Cellular Variation
    Key Molecular Interactions
    Base-Pair Complementarity
    Genetic Coding
    Interrupting Gene Segments
    Sequence Determinations
    Cloning
    Synthesized DNA
    Cell Lines
    Expression Systems

    Introduction to the Bioprocess


    Overview
    Optimizing Product Yield
    Kinetic Models
    cGMP Standards
    Contract Manufacturing
    Complex Mixtures
    Biomolecular Products
    Joint Manufacturing
    Downscaling to Scale Up
    Large-Scale Bioprocesses
    Scaling-Up In-House or in a Contract Facility
    Lab-to-Pilot-Plant-to-Production
    Increasing Bioprocess Scale
    Differing Features at Larger Scale
    Simulating Environment at Scale
    Detailed Specifications
    Impact on Downstream Bioprocessing
    FDA Biologics Review Process
    Regulating Biological Products

    Recombinant DNA Materials and Methods


    Cloning
    Applications
    Screening and Selection
    DNA Synthesis
    Cell Lines
    Expression Systems
    Vector Construction
    Prokaryotic and Eukaryotic Growth Characteristics
    Expression Levels
    Intra- vs. Extra-cellular Expression
    Intracellular Expression
    Extracellular Expression
    Glycosylation
    Mammalian Cell Glycosylation
    Insect Cell Glycosylation
    General Considerations
    Further Post-translational Modifications
    Economic Concerns
    Regulatory Concerns
    Manufacturers’ Directory

    Enzymes


    Overview
    Enzyme Protein Engineering
    Transformation in Non-Aqueous Systems
    Restriction Enzymes
    Restriction-Enzyme Classes
    Class I Restriction Enzymes
    Class II Restriction Enzymes
    Class III Restriction Enzymes
    Restriction-Enzyme Specificity
    Star Activity
    Enzyme Families and Compatible Ends
    Isoschizomers
    Reverse Transcriptases
    DNA and RNA Nucleases
    Manufacturers’ Directory

    DNA-Amplification Reagents


    Overview
    Amplification by DNA Synthesis (PCR)
    Amplification by RNA Transcription (TAS and 3SR
    Amplification by Ligation (LAR, LCR, LAS)
    Amplification by RNA Replication (Q Replicase)
    Sequence-Based Amplification
    Manufacturers Directory

    Cell-Culture Media


    Overview
    Prokaryotic Cell-Culture Medium
    Eukaryotic Cell-Culture Medium
    Defined Medium
    Serum
    Other Sera
    Serum Contamination
    Serum-Free (Defined) Medium
    Cell-Culture Gels
    Media Supplements
    Attachment Factors
    Buffers
    Sodium
    Earle’s Balanced Salt Solution
    Growth Factors
    Epidermal Growth Factor (EGF)
    Fibroblast Growth Factors (FGF)
    Acidic FGF
    Basic FGF
    Other Growth Factors
    Lectins
    Toxins
    Transport Factors
    Vitamins
    Water
    Manufacturers’ Directory

    Fermenters


    Introduction to Fermentation
    Historical Perspective
    The Fermentation Process
    Enzyme Fermentation in the Organic Phase
    Cell Growth and Production
    Factors Affecting Specific Growth Rate
    Kinetic Models
    Optimal Conditions
    Recombinant Culture Kinetics
    Fermenter Design
    Kinetic Modeling of the Fermentation Process
    STF Batch Scale Up
    Power Number Method for STF Geometric Scale Up
    Continuous-Culture Scale Up
    Fermenter Manufacturers Directory

    Bioreactors


    Introduction
    Aseptic Conditions
    Monoclonal Antibody Production
    mAB Production in Ascites Fluid
    Bioreactor Engineering and Design
    Bioreactors II: Kinetic Modeling and Bioreactor Dynamics and Bioreactor Design Program
    Bioreactor Manufacturers Directory

    Biomolecular Synthesizers


    DNA Synthesizers
    Manufacturers Directory
    Technology Overview
    Peptides by Solid-Phase Synthesis
    Manufacturers Directory
    Biotechnology Glossary
    References and Recommended Reading Index

    Biography

    William L. Hochfeld

    “This book is designed for biochemical  and biopharmaceutical engineers, technicians, scientists new to biotechnology, production staff, QA personnel, and managers. It is fully equipped with a biotechnology glossary, numerous references, and an exceptionally extensive index, and it emphasizes practical techniques, methods, and applications. This volume presents unparallel, detailed, and cutting-edge information on bioprocessing systems, and is a working reference and formulary for producing recombinant, bioactive, or other exotic proteins, peptides, and nucleic acids to specification. The text provides coverage of the related technologies, coupled with the extensive biotechnology glossary, manufacturer’s directories, extensive references, important formulae, charts, illustrations, comprehensive index, and emphasis on practical techniques, time-proven methods, and essential applications. These features combine with its easy-to-use layout making it an essential resource for all individuals involved in this interesting and fast developing area of bioscience.”
    — John F. Kennedy, Bo Liu, Chembiotech Laboratories, Institute of Research and Development, University of Birmingham Research Park, UK, in International Journal of Biological Macromolecules, 2007
    “This volume examines the bioproduction systems that support the controlled, automated, and quantity growth of proteins. The book discusses the substance, character, makeup, and quality of the basis materials used in the production and downstream processing of biomolecular materials: raw materials, reagents, intermediates, and consumables. … the text provides coverage of the related technologies, coupled with the extensive biotechnology glossary, manufacturer’s directories, extensive references, important formulae, charts, illustrations, comprehensive index, emphasis on practical techniques, time-proven methods, and essential applications. …”
    — In Anticancer Research, 2006
    “… effectively and extensively covers fermenters, bioreactors, and biomolecular synthesizers. It is must reading for those new to biopharmaceuticals and is a useful reference for the experienced. … The bibliography and list of recommended reading at the end of the book is very useful in making this book a single source for all the diverse information necessary for recombinant biotechnology fields. The price of the book is moderate and I strongly recommend this book for both academic libraries and for interdisciplinary courses. … can be used day to day by management, researchers, and plant operators. Many industries can use this book in their employee training programs. … the author must be congratulated for compiling a fine work on such a vast topic.”
    — Milind Deshpande, Technical Director, Fermentation and Processing Center for Biocatalysis and Bioprocessing, University of Iowa