Main description:

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.

Contents:

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