Cell Therapy : cGMP Facilities and Manufacturing /
| Autor Corporativo: | |
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| Otros Autores: | |
| Formato: | eBook |
| Lenguaje: | English |
| Publicado: |
New York, NY :
Springer US : Imprint: Springer,
2009.
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| Edición: | 1st ed. 2009. |
| Materias: |
Tabla de Contenidos:
- 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.