A Critical Focus on Automation in CGT Manufacturing (Part 2)

While automation is a critical focus for advancing cell and gene therapy (CGT) manufacturing, the primary goal is to automate sterile processing, which is a common challenge across all biologics, such as monoclonal antibodies, antibody-drug conjugates, and viral vectors, observes Edwin Stone, PhD, CEO of Cellular Origins, in the second half of an interview with BioPharm International®.

Stone notes how automation offers benefits beyond just increased capacity; it can also reduce errors and variability, especially as batch sizes grow. These benefits are crucial as industries look to the future of biology, including synthetic biology applications, in other areas such as agriculture and cultured meat. Scalable, automated sterile production will be enabling for these emerging technologies, Stone explains.

"Fundamentally … we're at [a] moment [where] we do not have enough biologists to manufacture the therapies we need. In fact, it's one of the interesting things. In many cases, when industries implement automation, I think has to be quite a politically sensitive thing, because there's concern that you're actually displacing workers. In this case, we still need all the workers we've got. We still need all the biologists. What we need to do is make them more productive and able to produce more therapies," Stone states.

One of the key challenges in CGT manufacturing is the shortage of skilled bioprocessing staff, Stone points out. However, he asserts that automation can increase productivity without displacing workers, though training and user-friendly design are critical. Stone does expect the skills base to expand, with biologists working alongside automation engineers—an evolution he notes is supported by government stakeholders focused on high-value manufacturing, with the ultimate goal of industrializing CGT production, while reducing costs and expanding global access to these treatments.

Click above for the full interview.

Click here for part one of this interview.

About the speaker

Edwin Stone, PhD, CEO, Cellular Origins

Edwin Stone has spent more than 20 years bringing new life science technologies to market, the last 10 of these focused on solving the challenges of cell therapy manufacturing. He established TTP’s cell and gene team which developed more than 10 cell therapy automation systems, including systems that are now in routine use for commercial therapy manufacture. Seeing the challenge of scale remained unaddressed, Stone co-founded Cellular Origins to enable patient access to cell therapies through scalable, cost-effective, and space-efficient manufacturing enabled by the Constellation automated cell therapy manufacturing platform. Stone holds a Master’s degree in Engineering and a PhD in robotic vehicles from the University of Cambridge.