CGT method validation controls-current practices and considerations
This presentation reviews the regulatory challenges faced in cell and gene therapy with a focus to identify and use appropriate analytical controls when dealing with both limited regulatory guidance and limited materials.
Within the topic of “lack of guidance”; this slide-deck will focus on the following challenges:
(i) what is considered appropriate controls and standards (working reference material vs in- house/commercially available).
(ii) what alternative materials can be used when materials are scarce.
(iii) if processes change, is the reference standard still relevant (i.e. bridging study considerations).
|biophorum - deliverables - CGT Method Validation Controls_Current practices and considerations_June 2023 - 02|
- Download 347
- File Size 0.00 KB
- File Count 1
- Create Date 27th June 2023
- Last Updated