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PDA Technical Report No. 81 (TR 81) Cell-Based Therapy Control Strategy (single user digital version)

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Gov. Price: $180.00Member Price: $180.00Nonmember Price: $325.00
  • Description
  • Table of Contents

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.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 3.45 MB)

Click here to order paper ship version (Item no. 01081).

*To purchase licensing, please contact PDA at [email protected].

Table of Contents:

Click here to download >>> Detailed Table of Contents
  1. Introduction
  2. Glossary and Abbreviations
  3. Product Profile
  4. Critical Quality Attributes
  5. Critical Process Parameters
  6. Critical Material Attributes
  7. Control Strategy
  8. Lifecycle Management
  9. Summary
  10. References

Figures and Tables Index

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