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Disposable Bioprocessing Systems




ISBN 9781138077003
Published March 29, 2017 by CRC Press
322 Pages 32 B/W Illustrations

 
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Book Description

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.

Table of Contents

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

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Author(s)

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.