Princeton University Library Catalog

Cell therapy : cGMP facilities and manufacturing / Adrian Gee, editor.

Format:
Book
Language:
English
Published/​Created:
New York : Springer, 2009.
Description:
xx, 256 p. : ill. (some col.) ; 24 cm.
Bibliographic references:
Includes bibliographical references and index.
Contents:
Pt. I. Regulatory -- Ch. 1. Regulation of Cell Product Manufacturing and Delivery: A United States Perspective -- Ch. 2. The Regulatory Situation for Academic Cell Therapy Facilities in Europe -- Ch. 3. A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia -- Pt. II. GMP Facility Design -- Ch. 4. University of Minnesota - Molecular and Cellular Therapeutics (MCT) -- Ch. 5. University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/ Immunological Monitoring and Cellular Products Laboratory (IMCPL) -- Ch. 6. Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT) -- Ch. 7. Design of a New GMP Facility - Lessons Learned -- Pt. III. Professional Cell Therapy Standards -- Ch. 8. AABB Cell Therapy Standards -- Ch. 9. Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT) -- Pt. IV. Facility Operations -- Ch. 10. Standard Operating Procedures -- Ch. 11. Staffing, Training, and Competency -- Ch. 12. Cleaning Procedures -- Ch. 13. Environmental Monitoring -- Ch. 14. Supply Management -- Ch. 15. Facility Equipment -- Ch. 16. Quality -- Ch. 17. Product Manufacturing -- Ch. 18. Product Review, Release, and Administration -- Ch. 19. Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products.
Subject(s):
ISBN:
  • 9780387895833 (hd.bd.)
  • 0387895833 (hd.bd.)
OCLC:
432990104
RCP:
C - S