Katharina Künzel, Boehringer Ingelheim Pharma, Analytical Dev. Biologicals, Biberach, Germany

Potency assays such as cell-based bioassays as well as ELISA binding assays are employed for release and stability testing of biologics and to study their structure function relationships. For each NBE, individual potency assays reflecting the mode of action need to be developed for routine analytics. The current procedures for potency assays require a number of complex and labor-intensive steps, which limit sample throughput and introduce sources of variability.

A full-automated and fully equipped Tecan Fluent pipetting robot was implemented for automation of complete assay procedures in order to significantly increase the throughput and robustness of bioassays. As manual input is only required to run the system for assay start, the automated assay procedure will furthermore free lab capacity and confer high flexibility. Full-automated pipetting robots can furthermore be used for even more complex applications, as DoEs, scheduling assays with multiple varying parameters.

Using the robotic system, the automation of cell-based bioassays as well as ELISA binding assays have been successfully conducted including seeding of cells, preparation of dilutions as well as further pipetting steps for addition of reagents and read-out substrates. Moreover, the integrated microplate-reader enables automated plate readout and analysis of results. In robustness experiments, the system was tested for accuracy, precision and repeatability parameters, which were compared to manual pipetting experiments.