Summary and Info
Content: 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(t) PadReactor(t) 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
More About the Author
Sarfaraz Khan Niazi (Urdu: سرفراز خان نیازی, Hindi: सर्फ़राज़ ख़ान नियाज़ी) was born in Lucknow, India in 1949; he migrated to Karachi, Pakistan in 1962, and to the United States in 1970. He is an expert in biopharmaceutical manufacturing and has worked in academia and in industry, and as an entrepreneur.
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