P-125-T - Evaluation of Automation to Reduce Operator Variability in GMP Bioassays

Cell based bioassays are notoriously difficult to train out in the regulated environment. One of the largest sources of variability impacting performance is that introduced by the operator. Even with the most well written analytical method, individual technique, skill and operator fatigue due to a need for hundreds of pipetting steps all play their part. Automation of bioassays can increase throughput, but in the QC testing environment of a GMP lab this is not usually a concern. More important is the ability to execute QC bioassays in a consistent manner to produce results that accurately estimate drug potency, often coupled with the need to complete testing within a defined window. Here we evaluate a semi-automated platform with a small footprint, such that it can operate within a biological safety cabinet. The purpose of the evaluation was to demonstrate that precise results could be generated for a bioassay that proved troublesome to train out, by significantly reducing operator pipetting requirements and hence mitigate operator error.