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Biopharmaceutical manufacturing. Volume 2, Unit processes
Title
Biopharmaceutical manufacturing. Volume 2, Unit processes / Sarfaraz Niazi, Sunitha Lokesh.
ISBN
9780750331791
9780750331784
9780750331777
9780750331807
Publication
Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) : IOP Publishing, [2022]
Physical Description
1 online resource (various pagings) : illustrations (some color).
Local Notes
Access is available to the Yale community.
Notes
"Version: 202201"--Title page verso.
Access and use
Access restricted by licensing agreement.
Biographical / Historical Note
Sarfaraz K. Niazi is an adjunct professor at the University of Illinois and University of Houston. Prof. Niazi has established numerous consulting businesses and start-up companies within the biopharmaceutical industry, including Pharmaceutical Scientist, Inc and Karyo Biologics, LLC. Sunitha Lokesh is the director of biomanufacturing operations at Pharmaceutical Scientist Inc., where she leads the identification and technology development of biopharmaceutical products.
Summary
This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. This volume covers the unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of operation, with complete details on equipment, compliance and yield improvement suggestions.
Variant and related titles
IOP ebooks.
Other formats
Also available in print.
Print version:
Format
Books / Online
Language
English
Added to Catalog
April 21, 2022
Series
[IOP release $release]
IOP ebooks. [2022 collection]
Bibliography
Includes bibliographical references.
Audience
Industry scientists, engineers, investors, developers and other manufacturers of biopharmaceutical products.
Contents
1. Understanding bioprocessing
1.1. Overview
1.2. Key considerations for the production of biotherapeutics
1.3. Chromatography methods
1.4. Process lifecycle
1.5. Costing
1.6. Facility design
1.7. Testing
1.8. Documentation process
1.9. Conclusion
2. Recombinant manufacturing system
2.1. Overview
2.2. Recombinant DNA
2.3. Expression systems
2.4. Conclusion
3. Cell line development
3.1. Overview
3.2. Overview of protein expression
3.3. Host cell engineering
3.4. Conclusion
3.5. Appendix
4. Upstream equipment and systems
4.1. Overview
4.2. Medium and solution preparation systems
4.3. Bioreactor systems
4.4. Harvest and clarification systems
4.5. Ancillary and peripheral equipment
4.6. Conclusion
5. Upstream processing
5.1. Overview
5.2. Culture media
5.3. Cell culture fermentation
5.4. Conclusion
6. Downstream process
6.1. Overview
6.2. E. coli system : recovery and purification
6.3. Mammalian system purification
6.4. Product concentration
6.5. Analytical methods
6.6. Downstream processing equipment and system components
6.7. Conclusion
7. Process and product lifecycle development
7.1. Overview
7.2. Process development
7.3. Process scale-up
7.4. Technology transfer
7.5. Process characterization and optimization
7.6. Process validation
7.7. Process control strategy
7.8. Testing methods
7.9. Conclusion
8. Quality and compliance systems
8.1. Overview
8.2. Quality system
8.3. Validation master plan
8.4. Good laboratory practices
8.5. Quality control
8.6. Regulatory compliance
8.7. Conclusion
9. Single-use technology
9.1. Overview
9.2. Single-use containers and mixing systems
9.3. Upstream processing
9.4. Connectors and transfer systems
9.5. Sampling
9.6. Downstream processing
9.7. Safety
9.8. Regulatory matters
9.9. Advantages
9.10. Conclusion
10. Advancements and trends in biomanufacturing
10.1. Overview
10.2. Cell line development
10.3. Upstream process intensification
10.4. Downstream
10.5. Continuous manufacturing
10.6. Process analytical technology (PAT)
10.7. Automation
10.8. Conclusion.
Also listed under
Institute of Physics (Great Britain), publisher.
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