A company has developed an iPhone-like bioreactor that may have the potential to aid quality control to validate the efficacy of cell therapies. The flat bioreactor, which has an inner section to hold various cell types, is designed to give a real-time 3D view of the tumor environment.
According to Massimo Dominici, MD, professor of medical oncology and scientific founder of Rigenerand, the technology should allow the validation of cell and gene therapies.
“The inner part of the bioreactor is a matrix of about 400 micrometers. That’s big enough to hold various cell types and at the same time keep them visible, so we can use biofluorescence markers to follow their fate,” he explained.
According to Rigenerand, which is working on cGMP gene and cell therapies, the company developed the bioreactor design for its own use. However, the team soon began to sell it as a standalone product.
“We soon realized it was useful as a product,” continued Dominici. “And the concept is to use it as an accelerator for validating the cell and gene therapy approach.”
The company is selling the bioreactor to rapidly validate CAR-T products against primary cells or cell lines during research and development, he said.
Patient response to immunotherapy
Another application, he pointed out, is in predicting the response of patients to a particular immunotherapy product after a tumor biopsy.
“You might isolate cells from a patient and then have an allogeneic CAR-T tester or checkpoint inhibitors that you can use in a 24-hour assay to predict whether an immunotherapy approach would work on that sample,” he explained, while predicting that the technology may be useful in the future for product testing of cell therapies after manufacturing, especially off-the-shelf products derived from donor cells.
“You need to have a product ready to be used because you need to have the time to collect the primary cells and then expand the lymphocytes to generate the CAR-T. That might take a couple of weeks and you have to keep the bioreactor [culture] alive for that time. So, that ideally might be an allogeneic CAR-T, alternatively you may use established cell lines as tester,” he said.
The team has validated the approach within autologous settings, he added. “At the moment, there aren’t many allogeneic CAR-Ts and it’s not been tested [on those], but it definitely has the flexibility, it’s definitely a prospect, and we’re definitely keeping it in mind.”