Part 1. Regulatory1. 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 & Gene Therapies in the United States
About the Author: Dr. Adrian Gee is currently Professor of Medicine & Pediatrics, Center for Cell & Gene Therapy at Baylor College of Medicine. He received his bachelor's degree from the University of Birmingham, England, and his Ph.D. from the University of Edinburgh, Scotland. He completed postdoctoral training at the National Institutes of Health and the University of Toronto. He then joined the faculty at the University of Florida where he performed some of the first applications of immunomagnetic tumor purging in the United States, and his laboratory became a central cell processing facility for this procedure. He co-founded the International Society for Hematotherapy and Graft Engineering (ISHAGE, now ISCT), and the Journal of Hematotherapy (now Cytotherapy) and helped establish the stem cell transplantation program at the University of South Carolina. He then directed the Cell Processing Laboratory at the University of Texas MD Anderson Cancer Center until he joined the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine in Houston. The CAGT houses GMP manufacturing facilities for vectors and cell therapy products, and has been selected as one of the 5 national somatic cell therapy processing centers by the National Heart, Lung & Blood Institute. Dr. Gee was involved in the development of standards for the collection processing and transplantation of hematopoietic stem cells for the Foundation for the Accreditation of Cell Therapy (FACT), the American Association of Blood Banks and the National Marrow Donor Program.
