This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (c GMP) 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 qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: c GMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.
Daftar Isi
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 (CMa T) .- 41. Financial Considerations for Academic GMP Facilities .- 42. Governmental Support Opportunities for Cellular & Gene Therapies in the United States.
Tentang Penulis
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.
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