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

Format:

Book

Author/Creator:

Niazi, Sarfaraz, 1949- author.

Lokesh, Sunitha, author.

Contributor:

Institute of Physics (Great Britain), publisher.

Series:

IOP (Series). Release 22.

IOP ebooks. 2022 collection.

[IOP release $release]

IOP ebooks. [2022 collection]

Language:

English

Subjects (All):

Pharmaceutical biotechnology.

Technology, Pharmaceutical.

Biotechnology.

Medical Subjects:

Technology, Pharmaceutical.

Biotechnology.

Physical Description:

1 online resource (various pagings) : illustrations (some color).

Place of Publication:

Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) : IOP Publishing, [2022]

System Details:

Mode of access: World Wide Web.

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

Biography/History:

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.

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.

Notes:

"Version: 202201"--Title page verso.

Includes bibliographical references.

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

Other Format:

Print version:

ISBN:

9780750331791

9780750331784

OCLC:

1303069435

Access Restriction:

Restricted for use by site license.