Cell Therapy: cGMP Facilities and Manufacturing (Hardcover)

Preface List of Contributors List of Acronyms Part I. Regulatory Chapter 1. Regulation of Cell Product Manufacturing and Delivery: A United States Perspective Chapter 2. The Regulatory Situation for Academic Cell Therapy Facilities in Europe Chapter 3. A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia Part II. GMP Facility Design Chapter 4. University of Minnesota - Molecular and Cellular Therapeutics (MCT) Chapter 5. University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/ Immunological Monitoring and Cellular Products Laboratory (IMCPL) Chapter 6. Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT) Chapter 7. Design of a New GMP Facility - Lessons Learned Part III. Professional Cell Therapy Standards Chapter 8. AABB Cell Therapy Standards Chapter 9. Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT) Part IV. Facility Operations Chapter 10. Standard Operating Procedures Chapter 11. Staffing, Training, and Competency Chapter 12. Cleaning Procedures Chapter 13. Environmental Monitoring Chapter 14. Supply Management Chapter 15. Facility Equipment Chapter 16. Quality Chapter 17. Product Manufacturing Chapter 18. Product Review, Release, and Administration Chapter 19. Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products