Fundamentals of Modern Bioprocessing - Sarfaraz K. Niazi

Fundamentals of Modern Bioprocessing

; Justin L. Brown

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. Les mer
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Vår pris: 962,-

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Leveringstid: Sendes innen 7 virkedager

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.
FAKTA
Utgitt:
Forlag: CRC Press
Innbinding: Paperback
Språk: Engelsk
Sider: 740
ISBN: 9781138893290
Format: 25 x 18 cm
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«

"… 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

»

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
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.