A team from the U.K.’s Cell and Gene Therapy Catapult has been using digital tools to aid the manufacturing of autologous therapies, personalized to individual patients, as well as allogeneic therapies that treat a larger patient population with donor cells.

According to Jahid Hasan, PhD, program head of cell delivery at CGT Catapult, digital tools can help reduce errors from paper-based batch management, as well as improve process analytics and manufacturing control.

“A key take-home is that everyone should be developing and integrating digital tools, if they’re not already, and also that it’s possible to see the benefits even with minimum levels of investment,” he says.

Hasan, who will be speaking about CGT Catapult’s work on implementing digital tools at Bioprocessing Summit Europe, says that one of the benefits is in improving the paper trail for batches of product.

“Manufacturing is heavily paper-based, which creates a lot of room for error, and it takes time to review and release products,” he says.

“We have a case study with a company called Autolomous where we’ve transitioned to their electronic system.” This has reduced quality assurance review effort by 65%, he says, and also increased batch throughput without changing production schedules.

Furthermore, digitized data entry achieved an 90% error reduction per batch. “That’s massive!” he adds.

Accelerating product development

According to Hasan, reducing error rates speeds up product development and increases the potential for advanced therapies to be delivered to a larger number of patients.

In addition, digitalizing and analyzing data can help mitigate the impact of donor variability when developing autologous therapies and improve process understanding when manufacturing allogeneic ones.

“With autologous, these patients can be very sick, as many currently approved autologous cell therapies are only prescribed as a last resort, so it’s essential that, once we start manufacturing, we complete a product that is efficacious for them,” he says.

Meanwhile, for allogeneic therapies involving induced pluripotent stem (iPS) cells, using datasets to create digital models to test cells in silico under different conditions can save lengthy periods of lab experimentation.

“One of the risks of iPS cells is that the manufacturing platform can differ significantly from the one the therapy was developed in,” he says. “If you can link your discovery platform to your manufacturing platform, you can streamline that scaling process.”

Digital tools can also be used to monitor and control processes remotely, Hasan says.

Going forward, he says that his team at CGT Catapult will be spending more time developing analytics for automating the production of allogeneic therapies.

“There’s a big push for allogeneic therapies, but the [clinical trials] starting now are the first ones in this space and the processes are first generation,” he adds.

“However, we can already see how people are starting to think about what they’re going to be doing in five or ten years, so we’re taking all our learning from autologous therapies to ensure that these digital capabilities are ready [to use].”