GE Healthcare says monoclonal antibodies laid the groundwork for its workflow technologies, allowing accelerated uptake of automation in the autologous cell and gene therapy space.

In May, bioprocessing tools and services firm GE Healthcare launched its Chronicle automation software for cell therapy manufacturing. The offering supports the complete workflow for cell therapy products including the optimization of manufacturing from process development to commercialization.

Talking to Bioprocess Insider at the BPI Theater at BIO in June, Catarina Flyborg, GM of GE’s cell and gene therapy business, said the launch is part of a strategy to fill in gaps in autologous CAR-T workflow.

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“We needed to have an automation platform that fits the purpose, not as sophisticated as a big volume biologics, but that meet the needs. Hence, we then developed Chronicle, which is a type of an MES [Manufacturing Execution System] system.

“It makes it possible to connect all the unit operations. It makes it possible to actually track what you have been working with, and so forth. That’s Chronicle. It’s an automation platform for the cell and gene therapy space.”

The service was born out of GE’s acquisition of Asymptote Limited in 2017. However, it has also benefitted from GE’s technology offerings and years of experience within the bioprocess space, Flyborg added.

“It illustrates the learnings we have all had in the biologics [space], the monoclonal story,” she said. “We are trying to accelerate it quicker than we did, remembering that we have learned a lot during these years.

She added when automation was first discussed for biologics, it took time to be incorporated in projects and processes. For cell therapies, “what we can do now is to somewhat accelerate it, and somewhat get it faster onto the market, and somewhat get it to the number of doses needed for the patients.”

Full digitalization

It is well documented that automation technologies are both necessary and a major investment area within the burgeoning cell and gene therapy space.

Manufacturers are incorporating elements of automation into their processes, for example closed loop process control and task automation. But according to Flyborg industry still needs to bring automation and analytics together to improve processes further and achieve a true vein to vein workflow.

“What is really needed is full digitalization to really make use of digital in its broader sense; not only the automation but also all the analytic,” she said.

Furthermore: “We need to come to a standardized sector. We need to get to a closed and automated system. That will take us to the platform that is needed in order to get it to the bigger volumes.”

This will, she continued, then lead to reduced costs and reduced risks.