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Stem Cell Production: Processes, Practices and Regulations
Hardcover
ISBN13: 9789811675881
Publisher: Springer Nature
Published: Mar 30 2022
Pages: 272
Weight: 1.27
Height: 0.69 Width: 6.14 Depth: 9.21
Language: English
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.-
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