Keywords:
Cytology.
;
Pharmacovigilance.
;
Facility management.
;
Cell Biology.
;
Drug Safety and Pharmacovigilance.
;
Facility Management.
Description / 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 & Gene Therapies in the United States.
Abstract:
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 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: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility. .
Type of Medium:
Online Resource
Pages:
X, 692 p. 107 illus., 75 illus. in color.
,
online resource.
Edition:
2nd ed. 2022.
ISBN:
9783030755379
URL:
https://doi.org/10.1007/978-3-030-75537-9
DOI:
10.1007/978-3-030-75537-9
DDC:
571.6
Language:
English
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