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Biopharmaceutical manufacturing. Volume 2, Unit processes / Sarfaraz Niazi, Sunitha Lokesh.

By: Niazi, Sarfaraz, 1949- [author.].
Contributor(s): Lokesh, Sunitha [author.] | Institute of Physics (Great Britain) [publisher.].
Material type: materialTypeLabelBookSeries: IOP (Series)Release 22: ; IOP ebooks2022 collection: Publisher: Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) : IOP Publishing, [2022]Description: 1 online resource (various pagings) : illustrations (some color).Content type: text Media type: electronic Carrier type: online resourceISBN: 9780750331791; 9780750331784.Subject(s): Pharmaceutical biotechnology | Technology, Pharmaceutical | Biotechnology | Pharmaceutical technology | Biomedical engineeringAdditional physical formats: Print version:: No titleDDC classification: 615.19 Online resources: Click here to access online Also available in print.
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.
Abstract: 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.
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"Version: 202201"--Title page verso.

Includes bibliographical references.

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.

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.

Industry scientists, engineers, investors, developers and other manufacturers of biopharmaceutical products.

Also available in print.

Mode of access: World Wide Web.

System requirements: Adobe Acrobat Reader, EPUB reader, or Kindle reader.

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.

Title from PDF title page (viewed on March 8, 2022).

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