Intelligent Biomanufacturing: Achieving Broad Access to Cell Therapy via Gene Editing and AI

PI: Krishanu Saha, professor of Biomedical Engineering

Co-PIs:

Tyler Ulland, associate professor of Pathology and Laboratory Medicine

Christian Capitini, professor of Pediatrics and director of the Carbone Cancer Center

Joshua Brockman, assistant professor of Biomedical Engineering

Melissa Skala, professor of Biomedical Engineering

Randy Bartels, professor of Biomedical Engineering

Christopher Bartley, director of Waisman Biomanufacturing

Description: Current cell therapies, like CAR T-cells, offer life-saving potential but face a “scaling problem” due to expensive, manual manufacturing and inconsistent cell quality. As T-cells are grown in the lab, they often become “exhausted” or dysfunctional, which can lead to treatment failure. This project introduces an “intelligent” biomanufacturing platform where engineered cells autonomously “clean” themselves. By programming high-functioning cells to recognize and eliminate their own dysfunctional counterparts—a process called “directed fratricide”—the team can ensure a high-purity, potent therapeutic product.

The team will combine this biological solution with advanced “Digital Twin” technology, using real-time optical sensors and AI to monitor cell health at the single-cell level. This approach transforms cell production from an unpredictable craft into a repeatable engineering science, creating affordable, “off-the-shelf” therapies for cancer and beyond.