This TR focuses on the development of a risk-based control strategy adapted to cell-based therapy that can mitigate the risk of generating a product of poor quality.
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Table of Contents:
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Detailed Table of Contents- Introduction
- Glossary and Abbreviations
- Product Profile
- Critical Quality Attributes
- Critical Process Parameters
- Critical Material Attributes
- Control Strategy
- Lifecycle Management
- Summary
- References
Figures and Tables Index