322 pages | 32 B/W Illus.
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
Appendix I: Complete Lines of Disposable Systems
Millipore Offers an Extensive Line (www.millipore.com)
Safety of Disposable Systems
Polymers and Additives
Partnering with Vendors
Responsibility of Sponsors
International Guidance and Standards
Proprietary Bag Suppliers
Generic Bag Suppliers
2D Fluid Containers
2D Powder Bags
Types of Mixing
Stirring Magnetic Mixer
Stirring Mechanical Coupling Mixer
CELL-tainer Cell Culture System
Stirred Single-Use Bioreactors
The Game Changers in Disposable Bioreactor Industry
Connectors and Transfers
Fittings and Accessories
Aseptic Transfer Systems
The Case of Monoclonal Antibodies: A GE Report
Filling and Finishing Systems
Robert Bosch Packaging Systems
PDC Aseptic Filling Systems
Irradiation and Sterilization Validation
Grind and Autoclave
Overall Environmental Impact
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
Out of Steam
The Stainless Challenge
High-Expression Cell Lines
Distilled Water Loops
Low Ceiling Heights
Multipurpose Disposable Bioreactors