James Lim, PhD, on Addressing Lingering Needs in Research Process Development and Clinical Manufacturing

“It's not enough to just create an assay. The assay needs to be pretty bulletproof, robust, and reproducible—and that's something that we're focused squarely on. And in general, to see all the activities with CAR-Ts—allogeneic, as well as autologous; the rise of in vivo gene therapies—our belief is that we're really at the precipice of a new direction within treatment interventions where we literally went from small molecules, antibodies a couple of decades later, and now we're dealing with actual living cells as a therapeutic entity. It's really exciting to see the field evolve and move so quickly. I think the benefit of all of this technology is, again: better outcomes, better survival, and better, safer options for the patients themselves.”

Although significant progress has been made in recent years, many challenges remain when it comes to culturing primary human cells for the purpose of manufacturing cell therapy products, such as chimeric antigen receptor T-cell (CAR-T) therapies. One area of interest for improvement is the development of new assays that more closely mimic physiological conditions than those assays that are currently used in the industry.

James Lim, PhD, the cofounder and chief scientific officer of Xcell Biosciences, coauthored a poster entitled, “Functional potency assay predicts CAR-T effectiveness in tumor microenvironment”, that was presented at the American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, 2023, in Orlando, Florida. The poster describes a novel cell killing assay method for CAR-T therapies that incorporates an incubation technology with discrete oxygen and pressure control in order to model aspects of the solid tumor microenvironment, namely hypoxia and high-pressure conditions.

In an interview with CGTLive™, Lim spoke about the challenges of cell therapy manufacturing and discussed Xcell Biosciences’ efforts to introduce new technologies to this space. He noted that primary human cells tend to require more maintenance in the culturing process than nonhuman cells that are commonly used in research, such as Chinese hamster ovary cells. Lim concluded by expressing general optimism about the amount of progress that has been made with advanced therapeutics in the past few decades.

Click here to read more coverage of the AACR 2023 Annual Meeting.

REFERENCES
1. Xing Y, Liu N, Czeryba N, et al. Functional potency assay predicts CAR-T effectiveness in tumor microenvironment. Presented at: AACR Annual Meeting. April 14-19, 2023; Orlando, FL. Abstract 1782.