1st Edition
Producing Biomolecular Substances with Fermenters, Bioreactors, and Biomolecular Synthesizers
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