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

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

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