Stem Cell Production : Processes, Practices and Regulations /
This book examines the technologies and processes for the development and commercial production of stem cells according to cGMP guidelines. The initial chapter of the book discusses the therapeutic potentials of stem cells for the treatment of various diseases, including degenerative disorders and g...
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| Format: | eBook |
| Language: | English |
| Published: |
Singapore :
Springer Singapore : Imprint: Springer,
2022.
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| Edition: | 1st ed. 2022. |
| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
Table of Contents:
- Chapter 1. Stem Cell Therapy: Significance and Applications of Stem Cell Products in the Tissue Engineering and Regenerative Medicine
- Chapter 2. GLP Requirements of Stem Cells
- Chapter 3. Current Good Manufacturing Practice (CGMP) Facility and Production of Stem Cell
- Chapter 4. Global Regulatory Frameworks and Quality Standards for Stem Cells Therapy and Regenerative Medicines
- Chapter 5. Stem Cell Bioreactors: Design, Structure and Operation of Stem Cell Bioreactors
- Chapter 6. Stem Cell Culture and Expansion: Role of culture, Types of Cells, Growth Conditions, Media Nutrients, Growth Factors, Growth Phase Cycle
- Chapter 7. UP Scaling of Clinical Grade Stem Cell Production-Upstream Processing (USP) and Downstream Processing (DSP) Operations of Cell Expansion, Harvesting, Detachment, Separation, Washing and Concentration Steps, and the Regulatory Requirements
- Chapter 8. Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and their Products According to Regulatory Requirements for FDA Approval
- Chapter 9. Stem Cell Safety and Sterility Testing: A Promising Approach in Regenerative Medicine
- Chapter 10. Stem Cells Storage, Packaging and Transportation
- Chapter 11. Stem Cell Clinical Trials and Stem Cell Market.-.