Biopharmaceutical manufacturing. Volume 2, Unit processes /

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 biol...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores principales: Niazi, Sarfaraz, 1949- (Autor), Lokesh, Sunitha (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Bristol [England] (Temple Circus, Temple Way, Bristol BS1 6HG, UK) : IOP Publishing, [2022]
Colección:IOP (Series). Release 22.
IOP ebooks. 2022 collection.
Temas:
Pharmaceutical biotechnology.
Technology, Pharmaceutical.
Biotechnology.
Pharmaceutical technology.
Biomedical engineering.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

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