1st Edition
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
Biography
Sarfaraz K. Niazi, Ph.D., is the founding executive chairman of Therapeutic Proteins International, LLC. He began his career teaching pharmacy at the University of Illinois, where he was a tenured professor, before entering the pharmaceutical industry with Abbott International, where he became a Volwiler fellow. Dr. Niazi is a licensed practitioner of patent law, has published numerous books and papers, and has been recognized with several awards for his contributions to science and literature. His inventions, philanthropy, and passion for science, literature, music, and photography have also been documented in publications such as Forbes, Chicago Tribune, and Crain’s Chicago Business.
Justin L. Brown, Ph.D., joined the biomedical engineering faculty of The Pennsylvania State University in 2010. Prior to joining Penn State, Dr. Brown spent seven years at the University of Virginia where he obtained his Ph.D. in biomedical engineering and completed a postdoctoral fellowship in cell and microbiology. His current research interests focus on exploring the signaling cascades and lineage commitment of mesenchymal stem cells in response to biomaterial surfaces that have potential for translation to clinical strategies. Dr. Brown’s lab applies both a reductionist and high-throughput systems approach towards understanding the mechanistic cellular response to extracellular biomaterial geometries.
"… destined to become a standard handbook for bioprocess engineers. It provides a detailed discussion of emerging areas, such as disposable bioreactors, that are scarcely covered in the books that are currently available."
—Jules Magda, University of Utah, Salt Lake City, USA
