Cell Therapy

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 MeasurementAssurance 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 & Gene Therapies in the United States.