QPS performs a wide range of cell based assays for drug potency evaluation

In toxin neutralizing assay (TNA), the cellular toxicity is induced by incubation of cells with the target toxin. Therapeutic drug reverse the cellular toxicity at a dose dependent manner, and the effect is measured by cell proliferation assays. TNA assays in preclinical species have been qualified at QPS with an inter-batch precision and accuracy both within ±25%.

The same concept can be applied to other cellular assay designs. The end point measurement can be cell proliferation, biomarker secretion, enzyme activities, etc.

ex vivo experiments

Phase I clinical studies are good opportunities to evaluate some established preclinical biomarkers in an ex vivo format. Blood incubation can be performed along the dosing period, and plasma collected for subsequent biomarker measurements. This type of proof-of-concept investigation has been used to obtain efficacy data in first-in-human studies.

In order to ensure sample integrity, QPS scientists have been travelling to the multiple clinical sites to set up the necessary facilities and performed the subsequent ex vivo experiments, before shipping the resulting plasma back to QPS for biomarker measurements.