CGT method validation controls bench-marking survey
The aim of this survey is to gather information to benchmark what analytical controls member companies are currently using to establish methods to test identity, strength, potency and purity. We are also looking to understand current practices member organizations undertake to help alleviate the issue of limited material for analytical controls. The survey will help the team to gain an understanding of some of the challenges companies are facing to establish a reference standard and/or assay controls.
The survey focused on practices/ challenges around securing material to use as analytical controls in release methods for all final DS/DPs. This survey covered all CGT therapy types and all phases of development.
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