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

Feb 2019
PDA Item Number

Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.

PDF Single user
Member Price
Nonmember Price
Government Price

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

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