Fundamentals of Modern Bioprocessing

Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to healthcare product manufacturing and expands on areas of opportunity for qualified bioprocess engineers and students. The book is divided into two sections: the first half centers on the engineering fundamentals of bioprocessing; while the second half serves as a handbook offering advice and practical applications. Focused on the fundamental principles at the core of this discipline, this work outlines every facet of design, component selection, and regulatory concerns. It discusses the purpose of bioprocessing (to produce products suitable for human use), describes the manufacturing technologies related to bioprocessing, and explores the rapid expansion of bioprocess engineering applications relevant to health care product manufacturing. It also considers the future of bioprocessing—the use of disposable components (which is the fastest growing area in the field of bioprocessing) to replace traditional stainless steel. In addition, this text: Discusses the many types of genetically modified organisms Outlines laboratory techniques Includes the most recent developments Serves as a reference and contains an extensive bibliography Emphasizes biological manufacturing using recombinant processing, which begins with creating a genetically modified organism using recombinant techniques Fundamentals of Modern Bioprocessing outlines both the principles and applications of bioprocessing engineering related to healthcare product manufacturing. It lays out the basic concepts, definitions, methods and applications of bioprocessing. A single volume comprehensive reference developed to meet the needs of students with a bioprocessing background; it can also be used as a source for professionals in the field.

Table of Contents:
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

About the Author :
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.

Review :
"I believe that Fundamentals of Modern Bioprocessing is 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 Madga, The University of Utah