As the allogeneic cell therapy industry moves beyond proof of principle experimentation and toward more human clinical trials, sponsors have a mighty challenge ahead of them: Growing more cells.
For example, a single patient dose of mesenchymal stem cell therapy could require hundreds of millions of cells or more. Because the cells themselves are the product, and that product, following downstream processing, goes to entire populations of patients, finding a way to scale up cell cultures while preserving underlying biology is essential.
That has historically been hard to do, according to Angel Garcia Martin, Ph.D., MBA, Business Development Manager at Corning Life Sciences. Culturing technologies that were available for early-phase cell therapy studies served lab-scale production just fine, but in the clinic, not so much. That's especially true for adherent cells.
"The kind of scale you need for allogeneic cell therapies can become unmanageable pretty quickly," says Garcia Martin. "Developers need a platform that can produce a ton of cells. While some cell lines have been adapted to support suspension cell cultures, most cells need to grow attached to a substrate. Up until recently, there has been no good technology out there that provides that kind of throughput these programs demand."
Scale Up Challenge Accepted
The recent development Garcia Martin alludes to is the advent of the Corning® Ascent® Fixed Bed Bioreactor (FBR) System, which enables efficient production and harvest of large quantities of cells in a cost-effective manner. Whereas previous FBRs supported the culture of adherent cells, researchers couldn't harvest the cells directly out of the reactor. That works for some cell-based products, but not for an autologous or allogeneic cell therapy. After all, if you can't effectively collect the cells, you don't have a product.
"The Ascent FBR system preserves the biology of the cells attached to the substrate," he said. "You can actually harvest the cells from the system and use them, which is a significant advantage."