Plugging the Gaps in Cell Therapy Manufacture

With the cell therapy industry expanding so rapidly, it can be difficult to keep up with the current gaps in product development and processes. But there are three main areas that need development, according to Marty Giedlin, PhD, SVP of process development, PACT Pharma.

“The first one is cryopreservation,” he says. “The industry is just beginning to investigate better ways of freezing cells and defrosting them again in the clinic. Some companies are starting to move away from using dimethyl sulfoxide (DSMO)-containing solutions to protect cells during the freezing process. Instead, they’re turning to amino acids or sugars, which have fewer downsides.

“Companies are also using more sophisticated instrumentation/assays to monitor the health of cells. They want information about metabolic activity, rather than just whether the cells are alive or dead.”

“Another gap is automation. People are still needed in a manufacturing facility. Some companies, such as Ori Biotech and Cellares, are making great progress on automating processes and minimizing the hands-on role of human operators,” notes Giedlin.

“Going along with automation is using analytics to assess how well a process is running and to automate the response,” he explains. For example, some companies have been talking about reactive analytics. That’s where, when an instrument detects a process is running below the set range, it might send a notice on an iPad or iPhone that the process dropped out of range, and this was what was done automatically to correct it.”

“Finally, Novartis has been talking over the last year about their T-Charge™ platform for making autologous CAR-T therapies. Unlike most CAR-T therapies, replication of the T cells doesn’t occur in an automated system, but inside the patient’s body. So, I think the coming new wave of T-cell therapies will take days, instead of weeks, to manufacture, and will also be more effective at treating patients.”

Giedlin will be speaking about disruptive technologies for addressing cell therapy manufacturing challenges at the Process Development for Cell Therapies Summit in Boston next month.

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