Abstract
The advent of stem cell therapy has created both opportunities for advanced patient care and challenges with respect to digital integration of data produced during manufacturing and treatment. The information needs to be stored in accessible formats providing details for instruments and consumables used to process raw materials to the therapeutic product. In this study, we used Chronicle™ automation software (Cytiva) as a proof of concept to enable digital integration and management of standard operating procedures used in a stem cell bioprocessing facility at Vanderbilt University Medical Center (VUMC). The digitization would provide reduction in variability from human error and immediate access to deviations while also freeing up skilled highly qualified personnel to process additional samples. We show that digital integration of the workflow provided tangible benefits in reduced operator time, ease of use, and data management. Future scope includes fully digitizing data collection and unit operations such as cell processing and cryopreservation.
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