Disposable Bioprocessing Systems.

• Author: Niazi, Sarfaraz K.
• Place / Publishing House: Milton : : Taylor & Francis Group,, 2011.; ©2012.
• Year of Publication: 2011
• Edition: 1st ed.
• Language: English
• Physical Description: 1 online resource (323 pages)

Table of Contents

Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Disclaimer -- Preface -- Author -- 1 The Bioprocessing Industry-An Introduction -- Summary -- Appendix I: Complete Lines of Disposable Systems -- Chromatography Columns -- 2 Safety of Disposable Systems -- Polymers and Additives -- Material Selection -- Testing -- Partnering with Vendors -- Responsibility of Sponsors -- Regulatory Requirements -- United States and Canada -- Europe -- Risk Assessment -- Appendix I: Use of International Standard ISO-10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" -- Background -- International Guidance and Standards -- 3 Containers -- Proprietary Bag Suppliers -- Generic Bag Suppliers -- Tank Liners -- 2D Fluid Containers -- 2D Powder Bags -- 3D Bags -- Transportation Container -- Summary -- 4 Mixing Systems -- Types of Mixing -- Stirring Magnetic Mixer -- Stirring Mechanical Coupling Mixer -- Tumbling Mixer -- Oscillating Mixer -- Peristaltic Mixer -- Summary -- 5 Disposable Bioreactors -- Xcellerex Bioreactor -- Cellexus Bioreactor -- CELL-Tainer Cell Culture System -- Wave-Mixed Bioreactors -- Stirred Single-Use Bioreactors -- Integrity™ PadReactor™ -- CellReady Bioreactor -- Orbitally Shaken Single-Use Bioreactors -- Bioreactor Selection -- The Game Changers in Disposable Bioreactor Industry -- Appendix I. Current Literature Survey of the Use of Disposable Systems -- 6 Connectors and Transfers -- Tubing -- Fittings and Accessories -- Pumps -- Aseptic Coupling -- Aseptic Connectors -- Welding -- Aseptic Transfer Systems -- Tube Sealers -- Sampling -- Conclusion -- 7 Controls -- Sampling Systems -- TRACE System -- Optical Sensors -- Biomass Sensors -- Electrochemical Sensors -- Pressure Sensors -- Conclusions -- 8 Downstream Processing -- The Case of Monoclonal Antibodies: A GE Report.

Membrane Chromatography -- Virus Removal -- Buffers -- Fluid Management -- Bioseparation -- Depth Filtration -- Ultrafiltration -- Integrated Systems -- 9 Filling and Finishing Systems -- Robert Bosch Packaging Systems -- PDC Aseptic Filling Systems -- Summary -- 10 Filtration -- Dead-End Filtration -- Cross-Flow Filtration -- Filtration Media -- Polymer Membranes -- Microfiltration Cross-Flow -- BioOptimal MF-SL™ -- TechniKrom™ -- GE Healthcare -- Spectrum -- Conclusion -- 11 Regulatory Compliance -- Regulatory Barriers -- Irradiation and Sterilization Validation -- 12 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 B-I: Risk Group 1 (RG1) Agents -- Appendix B-II: Risk Group 2 (RG2) Agents -- Appendix B-II-A: Risk Group 2 (RG2)-Bacterial Agents Including Chlamydia -- Appendix B-II-B: Risk Group 2 (RG2)-Fungal Agents -- Appendix B-II-C: Risk Group 2 (RG2)-Parasitic Agents -- Appendix B-II-D: Risk Group 2 (RG2)-Viruses -- Appendix B-III: Risk Group 3 (RG3) Agents -- Appendix B-III-A: Risk Group 3 (RG3)-Bacterial Agents Including Rickettsia -- Appendix B-III-B: Risk Group 3 (RG3)-Fungal Agents -- Appendix B-III-C: Risk Group 3 (RG3)-Parasitic Agents -- Appendix B-III-D: Risk Group 3 (RG3)-Viruses and Prions -- Appendix B-IV: Risk Group 4 (RG4) Agents -- Appendix B-IV-A: Risk Group 4 (RG4)-Bacterial Agents -- Appendix B-IV-B: Risk Group 4 (RG4)-Fungal Agents -- Appendix B-IV-C Risk Group 4 (RG4)-Parasitic Agents -- Appendix B-IV-D Risk Group 4 (RG4)-Viral Agents -- Appendix B-V: Animal Viral Etiologic Agents in Common Use -- Appendix B-V-1: Murine Retroviral Vectors.

Appendix K: Physical Containment for Large-Scale Uses of Organisms Containing Recombinant DNA Molecules -- Appendix K-I: Selection of Physical Containment Levels -- Appendix K-II: Good Large-Scale Practice (GLSP) -- Appendix K-III: Biosafety Level 1 (BL1)-Large Scale -- Appendix K-IV: Biosafety Level 2 (BL2)-Large Scale -- Appendix K-V: Biosafety Level 3 (BL3)-Large Scale -- Appendix K-VI: Footnotes of Appendix K -- Appendix K-VII: Definitions to Accompany Containment Grid and Appendix K -- 13 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.