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DoE is a crucial part during the development of potency assays at the Potency Assay Skill Center of Boehringer Ingelheim. The DoE approach is accelerating assay development as it allows the combination of several development experiments in one set. Therefore the total number and extend of assay runs needed is significantly reduced. Furthermore, it increases assay quality as it e.g. helps to identify 2-factor interactions which are only hardly detectable with the OFAT (one factor at the time) approach. Automation of DoEs is done to reduce variability of potency assays which improves the output of the DoEs. The process of DoE automation was split into two parts: Semi-automation of pipetting steps have been introduced in DoE experiments by using automated electronic multichannel pipettes. To further minimize handling time and to improve the assay throughput, fully automation of DoE by using an automation workstation is being established. Opportunities and challenges of the semi and fully automated DoE approaches will be shown.
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