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Disposable Bioprocessing Systems

Langue : Français

Auteur :

Couverture de l’ouvrage Disposable Bioprocessing Systems
Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the training of staff needed to include these components in existing bioprocessing systems. Not fully realizing the long-term benefits, many manufacturers are unwilling to discard investments made in fixed equipment and traditional stainless steel systems. Regulatory and environmental concerns, however, will eventually compel manufacturers to adopt disposable systems. Making a strong case for disposables, Disposable Bioprocessing Systems demonstrates the true potential of these systems.

Written by a researcher and professor with hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide, and creating model facilities using maximum disposable technology, this book is the first comprehensive introduction to understanding disposable systems. It gives an overview of the current state of the disposable bioprocessing industry, resolves all controversial issues, and guides readers in choosing disposable components that meet their needs. An important chapter on safety addresses facts and myths about the use of plastics and elastomers—including the issue of leaching—and how to ensure regulatory compliance.

Helping readers understand their choices, the book describes the equipment and systems available to prepare the starting materials for the manufacturing of biological drugs—from disposable containers to filters. The author also discusses costs, regulations, and concerns about waste disposal, and shares his predictions for the future of the disposable bioprocessing industry.

A practical manual for those interested in the transition to disposable systems, this book will also interest students of bioprocessing. It offers a timely view of disposable bioprocessing technology as a "game changer" that will facilitate developing new drugs and conducting research in the emerging field of stem cells and gene therapy.

The Bioprocessing Industry—An Introduction
. Summary
. Appendix I: Complete Lines of Disposable Systems
. Millipore Offers an Extensive Line (www.millipore.com)
. Chromatography Columns

Safety of Disposable Systems

. Polymers and Additives
. Partnering with Vendors
. Responsibility of Sponsors
. Regulatory Requirements
. Risk Assessment
. Background
. International Guidance and Standards

Containers

. Proprietary Bag Suppliers
. Generic Bag Suppliers
. Tank Liners
. 2D Fluid Containers
. 2D Powder Bags
. 3D Bags
. Transportation Container
. Summary

Mixing Systems
. Types of Mixing
. Stirring Magnetic Mixer
. Stirring Mechanical Coupling Mixer
. Tumbling Mixer
. Oscillating Mixer
. Peristaltic Mixer
. Summary

Disposable Bioreactors

. Xcellerex Bioreactor
. Cellexus Bioreactor
. CELL-tainer Cell Culture System
. Wave-Mixed Bioreactors
. Stirred Single-Use Bioreactors
. Integrity™ PadReactor™
. CellReady Bioreactor
. The Game Changers in Disposable Bioreactor Industry

Connectors and Transfers
. Tubing
. Fittings and Accessories
. Pumps
. Aseptic Coupling
. Aseptic Connectors
. Welding
. Aseptic Transfer Systems
. Tube Sealers
. Sampling
. Conclusion

Controls

. Sampling Systems
. TRACE System
. Optical Sensors
. Biomass Sensors
. Electrochemical Sensors
. Pressure Sensors
. Conclusions

Downstream Processing

. The Case of Monoclonal Antibodies: A GE Report
. Membrane Chromatography
. Virus Removal
. Buffers
. Fluid Management
. Bioseparation
. Depth Filtration
. Ultrafiltration
. Integrated Systems

Filling and Finishing Systems

. Robert Bosch Packaging Systems
. PDC Aseptic Filling Systems
. Summary

Filtration
. Dead-End Filtration
. Cross-Flow Filtration
. Filtration Media
. Polymer Membranes
. Microfiltration Cross-Flow
. Conclusion

Regulatory Compliance

. Regulatory Barriers
. Irradiation and Sterilization Validation

Environmental Concerns
. Biosafety
. Liquid Waste
. Incineration
. Pyrolysis
. Grind and Autoclave
. Landfill
. Treatment
. Overall Environmental Impact
. Summary
. Appendix B: Classification of Human Etiologic Agents on the Basis of Hazard
. Appendix K: Physical Containment For Large-Scale Uses of Organisms Containing Recombinant DNA Molecules

Epilogue

. Large Scale
. Integrity
. Flexibility
. Universal Use
. Scale-Up
. Cost
. Out of Steam
. Validation
. Leachables
. Animal Origins
. The Stainless Challenge
. Standardization
. Upstream
. Compliance
. High-Expression Cell Lines
. Flexible Factories
. Small Companies
. Unitary Systems
. Biosafety
. Autoclaves
. SIP/CIP
. Distilled Water Loops
. Low Ceiling Heights
. Modular Systems
. Gentle Mixing
. 2D Bags
. Fluoropolymer Bags
. Protein Capture
. Downstream Processing
. Closed Systems
. Molecule-Specific Facilities
. Max-Dispo Concept
. Leachables/Extractables
. Multipurpose Disposable Bioreactors

Bibliography
Index

Practitioners, scientists, and development/management teams at pharmaceutical and biotechnology companies; regulatory agencies worldwide; and graduate students in the biopharmaceutical sciences.
Sarfaraz K. Niazi has been teaching pharmaceutical sciences and conducting research in the field of drug and dosage form development for over 35 years. A former professor at the University of Illinois, Dr. Niazi has written over a hundred papers, dozens of books, and owns dozens of patents for his inventions in the field of drug development and biopharmaceutical processing, including patents on novel bioreactors. His first book on the subject, Handbook of Biogeneric Therapeutic Proteins (CRC Press), was widely received as a primer in the field of biological manufacturing. Niazi has hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide.

Date de parution :

Ouvrage de 322 p.

15.6x23.4 cm

Disponible chez l'éditeur (délai d'approvisionnement : 13 jours).

Prix indicatif 89,06 €

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