1st Edition

Disposable Bioprocessing Systems

By Sarfaraz K. Niazi Copyright 2012
    322 Pages 32 B/W Illustrations
    by CRC Press

    322 Pages 32 B/W Illustrations
    by CRC Press

    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

    Biography

    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. He lives in Deerfield, Illinois.