Comprehensive biotechnology Vol. 3/ principles and practices in industry agriculture medicine and the environment
Moo-Young,Murray
- Amsterdam: Elsevier, 2011.
- 690
3.01. Introduction
Acknowledgments
3.02. Industrial Enzymes
Glossary
3.02.1. Introduction
3.02.2. Protease
3.02.3. Lipase
3.02.4. Amylase
3.02.5. Pullulanases
3.02.6. Pectinases
3.02.7. Xylanase
3.02.8. Laccases
3.02.9. Transglutaminases
3.02.10. Phytase
3.02.11. Perspective
3.03. Multifunctional Enzyme Systems for Plant Cell Wall Degradation
Glossary
Acknowledgments
3.03.1. Introduction
3.03.2. Diversity of Multifunctional Enzymes
3.03.3. Inter- and Intra Molecular Synergism
3.03.4. Intra Molecular Synergism: Clues from Three-Dimensional Structures
3.03.5. Artificial Chimeras
3.03.6. Future Perspective
3.04. Ethanol Production from Sugar-Based Feedstocks
Glossary
3.04.1. Introduction
3.04.2. Feedstocks
3.04.3. Land Availability Scenarios
3.04.4. Feedstock Processing for Ethanol
3.04.5. Conclusions
3.05. Ethanol from Starch-Based Feedstocks
Glossary
3.05.1. Introduction
3.05.2. Biochemistry of the Ethanol Process
3.05.3. Yeasts Used in the Process
3.05.4. Unit Operations Relevant to Ethanol Production
3.05.5. Environmental Requirements in Fermentation
3.05.6. Yield Coefficient and Net Rate Expression
3.05.7. Metabolic Flux Analysis
3.05.8. Summary
3.06. Biofuels from Cellulosic Feedstocks
Glossary
3.06.1. Introduction
3.06.2. Cellulosic Biomass
3.06.3. Conversion of Cellulosic Biomass into Ethanol
3.06.4. Development of Microorganisms for Fermenting Cellulosic Biomass Hydrolyzates to Ethanol
3.35. Combination Products Are Not Solely Biological Products, Drugs, or Devices
Glossary
Acknowledgment
3.35.1. Introduction and Definitions
3.35.2. FDA’s Organization and the Office of Combination Products
3.35.3. Request for Designation, Primary Mode of Action, and Assignment of Jurisdiction
3.35.4. How Things Work – Differences in Processes between Centers
3.35.5. How Things Work – Similarities in Processes between Centers
3.35.6. The Future
3.35.7. Conclusions
3.36. Cellular Therapies
Glossary
3.36.1. Introduction
3.36.2. Sources of Cells and Clinical Applications of Cell Therapy
3.36.3. Cell-Based Products for Reconstructive or Structural Repair
3.36.4. Cellular Vaccines
3.36.5. Adoptive Cell Therapies
3.36.6. Stem Cell-Derived Therapies
3.36.7. Cell Isolation and Processing Methods
3.36.8. Summary
3.37. Gene Therapies
Glossary
3.37.1. Introduction and Scope
3.37.2. Current Status of Gene Therapy Products in Commerce and Clinical Development
3.37.3. Challenges Pertinent to the Development of Gene Therapy Products
3.37.4. Regulatory Issues and Standardization Activities Pertinent to Gene Therapy Products
3.37.5. Manufacturing of Gene Therapy Products
3.37.6. Vectors Employed in Gene Therapy Products
3.37.7. Manufacturing and Purification Strategies
3.37.8. Product Characterization
3.37.9. Process Validation
3.37.10. Product Administration of Gene Therapy Products
3.37.11. Conclusion
3.38. Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration
Glossary
3.38.1. Introduction
3.38.2. IND Applications
3.38.3. Biologic License Application
3.38.4. Comparability Testing
3.38.5. Communication with the FDA from Pre-IND through Licensure
3.38.6. Conclusions
3.39. Raw Materials in the Manufacture of Biotechnology Products
Glossary
3.39.1. Introduction: Raw Materials in the Biotechnology Industry
3.39.2. Regulations on Raw Materials
3.39.3. Considerations on Raw Materials
3.39.4. Impact of the Quality of the Raw Material on the Quality of the Final Biotechnology Product
3.39.5. Control of the Quality of Raw Materials
3.39.6. Life Cycle of a Raw Material in Biotechnology Products
3.39.7. Management of Raw Materials in the Context of ICH Guidelines
3.39.8. Controlling the Risk of Introducing Raw Materials
3.39.9. Future Directions
3.40. Characterization of Biotechnological/Biological/Biosimilar Products
Glossary
3.40.1. Assessment of Product Characteristics
3.40.2. Biotechnology Product Characterization, Comparability, Release, and Stability Tool Kits
3.40.3. Selection of Analytical Methods
3.40.4. Analytical Method Lifecycle Issues
3.40.5. Conclusions
3.41. Protein Glycosylation
Glossary
3.41.1. Introduction
3.41.2. Analysis of Intact Glycoproteins and Glycopeptides
3.41.3. Analysis of Free Glycans
3.41.4. Analysis of Monosaccharides
3.41.5. Glycan Analysis Design for Therapeutic Glycoproteins
3.42. Immunogenicity Assay Development and Validation
Glossary
3.42.1. Introduction
3.42.2. Development of Binding Antibody Methods
3.42.3. Validation of Binding Antibody Methods
3.42.4. Development of NAb Methods
3.42.5. Validation of NAb Methods
3.42.6. Practical Considerations and Recommendations
3.42.7. Concluding Remarks
3.43. Process Analytical Technology in Bioprocess Development and Manufacturing
Glossary
3.43.1. Introduction and Scope
3.43.2. PAT Tools
3.43.3. Concluding Remarks
3.44. Process Validation
Glossary
3.44.1. Introduction and Scope
3.44.2. General Requirements and Considerations
3.44.3. Process Knowledge
3.44.4. Validation of the Commercial Process
3.45. Follow-On Protein Products
Glossary
3.45.1. Introduction
3.45.2. Unique challenges associated with protein products
3.45.3. Impact of the manufacturing process on product quality
3.45.4. Impact of product quality on clinical performance
3.45.5. Conclusions
3.46. Amino Acid Production
Glossary
3.46.1. Introduction
3.46.2. Microbial Production
3.46.3. Enzymatic Production
3.46.4. Future Prospects
3.47. Lysine
Glossary
Acknowledgment
3.47.1. Introduction
3.47.2. Biological Properties and Applications of d-Lysine, ε-Poly-l-Lysine, and l-Lysine
3.47.3. History of Industrial l-Lysine Production
3.47.4. Different Commercial Production Methods for l-Amino Acids
3.47.5. Fermentation Is the Dominant Method for Industrial l-Lysine Production
3.47.6. The l-Lysine Biosynthetic Pathway from Aspartate
3.47.7. Metabolic Engineering of C. glutamicum for l-Lysine Overproduction
3.47.8. Alternative Raw Materials and Production Strains for l-Lysine Production
3.47.9. Conclusions and Perspectives
3.48. Food-Grade Enzymes
Glossary
Acknowledgments
3.48.1. Introduction
3.48.2. Sources of Food-Grade Enzymes
3.48.3. Food-Grade Enzymes Targeted at Processing
3.48.4. Food-Grade Enzymes Targeted at Preservation
3.48.5. Production of Food-Grade Enzymes
3.48.6. Recovery of Food-Grade Enzymes
3.48.7. Polishing of Food-Grade Enzymes
3.48.8. Safety Concerns with Food-Grade Enzymes
3.49. Proteases
Glossary
3.49.1. Introduction
3.49.2. Protease Types
3.49.3. Principal Industrial Sources/Production Processes
3.49.4. Principal Applications of Proteases
3.49.5. Protease Inhibitors
3.50. Application of Enzymes and Microbes for the Industrial Production of Vitamins and Vitamin-Like Compounds
Glossary
3.50.1. Introduction and Scope
3.50.2. Riboflavin – Vitamin B2
3.50.3. Niacin – Vitamin B3
3.50.4. R-Pantothenic Acid and R-Panthenol – Vitamin B5 and Provitamin B5
3.50.5. Biotin – Vitamin B7
3.50.6. Cobalamin – Vitamin B12
3.50.7. l-Ascorbic Acid – Vitamin C
3.50.8. Phylloquinones and Menaquinones – Vitamin K
3.50.9. Coenzyme Q10
3.50.10. Pyrroloquinoline Quinone
3.50.11. l-Carnitine
3.50.12. Outlook
3.51. Fungal Biotechnology in Food and Feed Processing
Glossary
3.51.1. Introduction
3.51.2. Use of Fungi in Dietary Food
3.51.3. Use of Fruiting Body
3.51.4. Fungi as and in Processed Food
3.51.5. Processed Fungal Food as an Alternative to SCPs
3.51.6. Use of Enzymes in Food and Feed Bioprocessing
3.51.7. Fungal Enzymes Used in Feed
3.51.8. Commercial Recombinant Enzymes from Fungi
3.51.9. Secondary Metabolites from Fungi used in Food and Feed
3.51.10. Pharmaceutical and Nutraceutical Byproducts from Fungi
3.51.11. Symbiotic Fungus Termitomyces: A Filamentous Basidiomycota
3.51.12. Termitomyces clypeatus: An Edible Fungus and Producer of Enzymes
3.51.13. Bioprocessing of Food by T. clypeatus
3.51.14. Concluding Remarks and Future Prospects
3.52. Metabolic Engineering
Glossary
3.52.1. Introduction: Evolution of Metabolic Engineering
3.52.2. Biological Systems
3.52.3. Desired Products
3.52.4. Engineering Strategies
3.52.5. Future Perspectives
3.53. Synthetic Biology
Glossary
3.53.1. Introduction
3.53.2. Historical Foundation
3.53.3. Foundational Research and Development
3.53.4. Enabling Technologies
3.53.5. Research and Education
3.53.6. Applications of Synthetic Biology
3.53.7. Regulatory Debate
3.53.8. Synbioethics
3.53.9. Intellectual Property
3.53.10. Looking Ahead
3.54. Industrial Biotechnology and Commodity Products
Glossary
3.54.1. Introduction
3.54.2. Upstream Activities
3.54.3. Downstream Activities
3.54.4. General Components
3.54.5. Future Designs and Facility Layouts
3.55. Bioreactors for Commodity Products
Glossary
3.55.1. Introduction
3.55.2. Classifications of Bioreactors
3.55.3. Types of Bioreactors
3.55.4. Bioreactors and Sustainability
3.56. Integrating Process Scouting Devices (PSDs) With Bench-Scale Devices
Glossary
3.56.1. Introduction
3.56.2. Process Scouting Devices Challenges
3.56.3. Integrating PSDs with Bench-Scale Devices by Developing a Scale-Up Strategy
3.56.4. Types of Process Scouting Devices
3.56.5. Future Developments
3.56.6. Conclusion
3.57. Overview of Downstream Processing in the Biomanufacturing Industry
Glossary
3.57.1. Introduction and Scope
3.57.2. Principles of DSP
3.57.3. Clarification Methods in DSP
3.57.4. Chromatography for Product Capture and Polishing
3.57.5. Filtration Methods Used in Product Purification and Formulation
3.57.6. Crystallization as a Low-Technology Polishing Method
3.57.7. Current Trends in the Biomanufacturing Industry
3.58. Nanotechnology
Glossary
3.58.1. Introduction
3.58.2. Types of Nanotechnology
3.58.3. Bionanotechnology and Nanobiotechnology
3.58.4. Nanotechnology at the Biological Interface
3.59. Biosurfactants
Glossary
3.59.1. Introduction
3.59.2. General Aspects
3.59.3. Applications
3.59.4. Perspectives and Future Development
3.59.5. Perspectives for Future Development
3.60. Bioleaching and Biomining for the Industrial Recovery of Metals
Glossary
3.60.1. Introduction
3.60.2. Microorganisms Involved in Biomining
3.60.3. Industrial Biomining of Ores
3.60.4. Environmental Impact of Biomining Activities
3.60.5. Microbial Metal Solubilization Mechanisms
3.60.6. Importance of Molecular Biology Studies in Metal Extraction
3.60.7. Perspectives
3.61. Biological Control
Glossary
3.61.1. Introduction
3.61.2. Biological Control
3.61.3. Biopesticides Classification
3.61.4. Biopesticide Categories
3.61.5. Biological Control of Aflatoxin Contamination of Crops