Chargement en cours…
Cell Therapy cGMP Facilities and Manufacturing /
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...
| Cote: | Libro Electrónico |
|---|---|
| Collectivité auteur: | |
| Autres auteurs: | |
| Format: | Électronique eBook |
| Langue: | Inglés |
| Publié: |
New York, NY :
Springer US : Imprint: Springer,
2009.
|
| Édition: | 1st ed. 2009. |
| Sujets: | |
| Accès en ligne: | Texto Completo |
Table des matières:
- I. Regulatory
- Regulation of Cell Product Manufacturing and Delivery: A United States Perspective
- The Regulatory Situation for Academic Cell Therapy Facilities in Europe
- A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia
- II. GMP Facility Design
- University of Minnesota - Molecular and Cellular Therapeutics (MCT)
- University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL)
- Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT)
- Design of a New GMP Facility - Lessons Learned
- III. Professional Cell Therapy Standards
- AABB Cell Therapy Standards
- Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT)
- IV. Facility Operations
- Standard Operating Procedures
- Staffing, Training, and Competency
- Cleaning Procedures
- Environmental Monitoring
- Supply Management
- Facility Equipment
- Quality
- Product Manufacturing
- Product Review, Release, and Administration
- Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products.