Disposable Bioprocessing Systems.

Disposable Bioprocessing Systems.

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

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