Adventitious Agent Detection in Cell Therapies

In the detection of adventitious agents in bioprocessing, it is necessary to detect the lowest abundance of virus or bacterial cells, often contained in a large volume of the original sample. The current sample preparation workflow is not adequate to handle this challenge, therefore limiting the lower limit of detection regardless of the downstream sensing methodologies used. In this presentation, I will demonstrate that we can address this sample preparation challenge directly by introducing an efficient electrokinetic concentration system, which can concentrate dilute detection targets (various adventitious agents) from a large sample volume (~100mL) into a small volume (as small as ~10pL), achieving an extremely high level of effective signal enhancement for downstream detection. This may allow direct, non-amplifying detection of the target biomolecules, which could enable rapid, real-time monitoring of various targets. Using the system, we have demonstrated that low abundance viral and bacterial targets below ~1CFU/ml can be concentrated and detected reliably by collecting low abundance targets from a large volume of the original sample (1~100mL). Interfacing with both amplifying and non-amplifying detection modalities is showcased.