Cell Therapy : cGMP Facilities and Manufacturing /
This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualificati...
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| Format: | eBook |
| Language: | English |
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Cham :
Springer International Publishing : Imprint: Springer,
2022.
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| Edition: | 2nd ed. 2022. |
| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
Table of Contents:
- Part 1. Regulatory.-1. Regulation of Cell Therapy in the United States.-2. Regulatory Landscape and Emerging Trends In Advanced Therapies Manufacturing: An EU Perspective.-3. Australian Cellular Therapy Regulations
- 4. Landscape for Regenerative Medicine Manufacturing in Japan
- 5. GLP Regulations for Non-clinical studies
- 6. Ethical Considerations in Cell Therapy
- 7. Investigational New Drug Applications for Cell Therapy Products
- 8. FDA Inspections
- 9. Commercialization of Investigational Cell Therapy Products
- Part 2 Quality Systems
- 10. The Meaning of Quality
- 11. Development and Maintenance of a Quality Program
- 12. Quality Control of Cellular Therapy Products and Viral Vectors
- 13. Quality Management Software - Q-Pulse
- 14. Selection of Contract Manufacturing and Testing Organizations
- Part 3 Facility Design
- 15. Introduction: Facility Design
- 16. PACT CPFs - Examples Describing Different Cell Processing Facility Designs
- 17. Design and Operation of a Multiuse GMP Facility at the City of Hope
- 18. Design and Operation of a Multiuse GMP Facility at the University of Miami
- 19. Design of a New Academic GMP Facility for Today and Beyond at the Dana-Farber Cancer Institute
- 20. Design and Licensure of an American Cord Blood Bank
- 21. Indiana University Vector Production Facility (IUVPF)
- 22. Qualification and Commissioning of a New GMP Facility
- Part 4 Facility Infrastructure
- 23. Environmental Monitoring
- 24. GMP Facility Cleaning and Maintenance
- 25. GMP Documentation
- 26. Process Validation
- 27. Equipment Qualification
- 28. Vendor Qualification and Supply Management
- 29. Staffing, Training and Competency
- Part 5 Product Management
- 30. Product Accessioning, Tracing and Tracking
- 31. ISBT 128 in Labeling of Cellular Therapy Products
- 32. Product Processing, Manufacturing and Administration
- 33. Transport and Shipment of Cellular and Gene Therapy Products
- 34. Regenerative Medicine: The Newest Cellular Therapy
- 35. Cellular Therapy Applications for COVID-19
- Part 6 Professional Standards and Support Organizations
- 36. Professional Standards for Cellular Therapy: The Foundation for the Accreditation of Cellular Therapy (FACT)
- 37. AABB Cell Therapy Standards
- 38. USP Standards for Cell-based Therapies
- 39. The Role of the National Institute of Standards Measurement Assurance for Cell Therapies
- 40. National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT)
- 41. Financial Considerations for Academic GMP Facilities
- 42. Governmental Support Opportunities for Cellular and Gene Therapies in the United States.