We test every cell therapy lot for potency, viability and identity before it goes to a clinic.
The laboratory measures the potency, viability and identity of cell therapy products on behalf of clinical partners. Each assay follows a written method, and the method is validated before it is used on a study.
Potency assays
A potency assay measures whether the cells still perform the function for which they were manufactured. The laboratory uses cytokine release and cytotoxicity assays, and the choice of assay is agreed with the sponsor for each product.
Viability by flow cytometry
Viability is determined by flow cytometry on fresh and on thawed samples. The laboratory reports the percentage of viable cells together with the total cell count and the gating strategy used.
Identity by marker panels
Identity is confirmed with panels of surface markers, which are read on the same instruments as the viability assays. The panels are fixed for each product and are changed only through a documented method amendment.
We work to Good Laboratory Practice, and every result we release carries two signatures.
The laboratory works under Good Laboratory Practice (GLP) and is inspected by the Swiss GLP monitoring authority. Raw data are kept in the study archive, and each study has a study director who answers for the conduct of the work.
Each report is reviewed by the quality unit and signed by the study director before it is released to the sponsor. Thomas Brunner, quality manager, leads the quality unit and carries out the internal audits.
