Cell Therapy

1. Regulation of Cell Product Manufacturing and Delivery: A United States Perspective
R.W. Lindblad

2. The Regulatory Situation for Academic Cell Therapy Facilities in Europe
I. Slaper-Cortenbach, M. Scott, D. Herrmann, M. Introna, K. Theunissen, P. Theocharous, C. Chabannon

3. A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia
A. Farrugia

4.
University of Minnesota – Molecular and Cellular Therapeutics (MCT)
D.H. McKenna

5.
University of Pittsburgh Cancer Institute – Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL)
D.L. Griffin, A.D. Donnenberg, T.L. Whiteside

6.
Baylor College of Medicine – Center for Cell and Gene Therapy (CAGT)
A. Gee

7. Design of a New GMP Facility – Lessons Learned
A. Gee

8. AABB Cell Therapy Standards
Z.M. Szczepiorkowski, E. Nunes

9. Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT)
P.I. Warkentin

10. Standard Operating Procedures
C.G. Lindgren

11. Staffing, Training, and Competency
D.M. Kadidlo

12. Cleaning Procedures
A. Gee, D.L. Lyon

13. Environmental Monitoring
A. Gee, D.L. Lyon

14. Supply Management
A. Gee, C.M. Rooney

15. Facility Equipment
D.L. Griffin

16. Quality
J.W. Atkins

17. Product Manufacturing
A. Gee

18. Product Review, Release, and Administration
N.H. Collins

19. Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products
E.J. Read, H.M. Khuu

Avainsanat: Life Sciences, Cell Biology