PDA Technical Report No. 81 (TR 81) Cell-Based Therapy Control Strategy (single user digital version)
- Published
- Feb 2019
- ISBN
- 9781945584060
- Pages
- 58
- PDA Item Number
- 43538
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- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
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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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Format: PDF (1 file 3.45 MB)
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Table of Contents
Table of Contents:
Click here to download >>> 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