Fundamentals of Modern Bioprocessing

ENGINEERING FUNDAMENTALS OF BIOPROCESSING Frontiers of Bioprocessing Defining Bioprocessing Current and Emerging Trends in Bioprocess Engineering Materials Advances Nanoscale Advances Bioprocessing for Chemical and Biologic Product Manufacturing Bioprocessing Leaders Worldwide Economic Predictions and Careers in Bioprocess Engineering Skills Needed for Future Bioprocess Engineers Appendix A: A Time Line of Biotechnology Development Introduction to Molecular Biology Introduction Building Blocks of Life: DNA, RNA, and Proteins DNA Replication Transcription Translation Genes Mutations Chromosome DNA Cloning Introduction to Biochemistry Introduction DNA Structure RNA Structure Protein Structure and Function Carbohydrates Lipids, Fats, and Steroids Basic Metabolic Pathways Introduction to Cellular Microbiology Introduction General Cell Structure Eukaryotes, Prokaryotes, Archaea, and Viruses Intracellular Organelles Cellular Transport Intracellular Signal Transduction Reaction Stoichiometry, Thermodynamics, and Kinetics Introduction Mass and Energy Balances Fundamentals of Chemical Reactions Basic Mass Transfer: Diffusion and Convection Basic Fluid Dynamics Basic Thermodynamics Basic Reaction Kinetics Kinetics of Enzymes and Cell Growth Introduction Basic Michaelis-Menten Kinetics Michaelis-Menten Kinetics with Inhibition pH and Transport Limitations Other Enzyme Kinetics Prokaryotic and Eukaryotic Growth Models Advanced Prokaryotic and Eukaryotic Growth Models Data Management Introduction Good Laboratory Practices Electronic Data Handling Data Errors Statistical Analysis Data Conclusions Flow Diagrams Exercises and Solutions HANDBOOK OF BIOPROCESSING Elements of Bioprocessing Introduction Upstream Processing Bioreactor Downstream Processing Genetically Modified Organisms Introduction Cell Line Characterization Characterization of Cell and Virus Banks Cell Line Construction Designing GMCS Vector Host Systems Expression System in E Coli Configuration of Efficient Expression Vectors Protein Production Genetic Manipulations to Improve Yield Manufacturing Overview Introduction Cell Culture Expression Systems Transgenic Animals Cell Lines and Characterization Media Culture Growth Extraction, Isolation, and Purification Capture Purification Impurity Removal Validation Intermediate Purification Polishing Formulation Process Overview Tech Transfer and Documentation Validation Scale Up Specific Economy Issues Process Materials Environment Control Good Manufacturing Controls of Active Pharmaceutical Ingredients Manufacturing Systems and Layout Cleaning Procedures Processing and Filling Laboratory Testing Laboratory Controls Documentation Technical Package Outsourcing in Biotech Manufacturing Issues to Discuss Disposable Bioprocessing Systems Introduction Safety of Disposable Systems Regulatory Matters Risk Assessment Disposable Containers Tank Liners Mixing Systems Disposable Bioreactors Disposable Connectors and Transfers Disposable Control and Monitoring Systems Downstream Processing Filtration Upstream Processing Introduction Bioreactors Batch Culture Continuous Culture Fed-Batch Culture Perfusion Culture Suspension Culture Microcarrier Support Roller Bottle Culture System Spinner Flask Culture Other Scale up Options Wave Bioreactor Cell Cube Technology Rotary Culture System Media Scaling and Production Costs Problem Resolution in Fusion Protein Expression Downstream Processing Introduction Capture System Suitability Downstream Processing Systems Process Flow Purification Introduction Protein Properties Affinity Chromatography Immobilized Metal Affinity Chromatography Anion Exchange Chromatography Cation Exchange Chromatography Size Exclusion Chromatography Reversed Phase Chromatography Hydroxyapatite Chromatography Hydrophobic Interaction Chromatography Scale-up and Optimization Manufacturing Systems Bacterial Expression Systems Genetically Modified Bacteria Mammalian Cells Manufacturing Systems Yeast Cell Expression System Insect Cells Systems Quality Consideration Introduction Management Responsibilities Resources Manufacturing Operations Evaluation Activities Conclusion QA Systems Validation Master Plan Raw Materials Column Life Process Virus Validation Testing of Product In-Process Control Regulatory Affairs Regulatory Issues Protein Degradation Stability Considerations Intellectual Property Introduction Patenting Systems and Strategies The Patent Laws Types of Patent Laws Anatomy of a Patent Patentability Patentability and Technical Information Search Components of a Patent Application Inventions of Interest to Pharmaceutical Scientists Biotechnology Inventions Patenting Strategies Bibliography