Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library.
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
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Verfasserangabe:
Adrian Gee, editor
Jahr:
2009
Verlag:
New York, NY, Springer
Aufsätze:
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Interessenkreis:
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Monographien
ISBN:
9780387895833
2. ISBN:
0-387-89583-3
Beschreibung:
XX, 256 S. : Ill., graph. Darst.
Sprache:
englisch||
Fußnote:
Literaturangaben
Mediengruppe:
Ausleihbestand