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.

Fully updated and expanded second edition reflects all recent developments and changes in the field

Comprehensive coverage of essential information from ethical considerations and facility management to product tracing and labeling, staff training and much more

Covers other essential topics like quality management, professional standards, writing/maintaining Standard Operating Procedures, financial considerations for academic facilities, future directions, etc.

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.