Buch, Englisch, 256 Seiten, Paperback, Format (B × H): 155 mm x 235 mm, Gewicht: 423 g
cGMP Facilities and Manufacturing
Buch, Englisch, 256 Seiten, Paperback, Format (B × H): 155 mm x 235 mm, Gewicht: 423 g
ISBN: 978-1-4614-9793-6
Verlag: Springer US
Additional topics in Cell Therapy: cGMP Facilities and Manufacturing…Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.
Zielgruppe
Research
Autoren/Hrsg.
Fachgebiete
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Vorklinische Medizin: Grundlagenfächer Humangenetik
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Klinische und Innere Medizin Gentherapie
- Naturwissenschaften Biowissenschaften Molekularbiologie
Weitere Infos & Material
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