Fabian Gerlinghaus
The Power List 2021 – Advanced Medicine
Co-Founder and Chief Executive Officer at Cellares
“The biggest challenge commercial cell therapy developers are facing is their inability to scale manufacturing to meet patient demand. The one-dose-at-a-time approach is highly labor-intensive, failure prone, and extremely difficult to scale with manual methods. For example, to produce 10,000 patient doses, one needs to run 10,000 separate manufacturing processes – each of which takes weeks and includes around 50 manual processing steps and 80 hours of touch time. This is a logistical nightmare; even the most pioneering companies in the cell therapy field struggle to treat a few thousand patients per year because of the lack of scalable manufacturing technologies. But I’m most excited about the creation of true end-to-end automation of cell therapy manufacturing platforms as they’ll help accelerate access to life-saving cell therapies by resolving this manufacturing bottleneck. At Cellares, we believe the industry must move beyond ‘semi-automated’ processes, and toward the adoption of true automation. This is critical to de-risking the manufacturing process, reducing costs, and the risk of manufacturing failures, enabling cell therapy companies to treat significantly larger patient populations.”