Device Development

Development of novel, potentially groundbreaking manufacturing equipment and consumables for cell therapies is a complicated dance. It is a delicate balance of conflicting development and commercial priorities against customer requirements and the need to get to market quickly. In this case a client came to DHC concerned with the progress of their internal development program and worried about the maturity of their integrated bioreactor system for the manufacture of CAR-T and next generation cell therapies.

Our clients may experience a variety of situations that lead to a leadership gap within their organizations. Senior staff at Dark Horse possess years of leadership experience and can help fill the gap and keep operations moving forward. With senior staff available for nearly any technical or strategic need (and the ability for each of them to call upon 40+ technical SMEs for additional support), this has become a common request for DHC.

When a company develops a product for use in a cell and gene therapy process, one of the steps is to get that product (complete with any consumables for use) approved. This client asked for assistance in the associated regulatory process.

This study highlights a custom piece of manufacturing equipment for a cell therapy client. In addition to engineering oversight, DHC also provided regulatory and PM support.