Pinpointing correlations for quality by integrating process and data analytics

Cell-based therapies and diagnostics are promising medicines to treat disease and injury, ranging from a child’s blood cancer to an otherwise healthy athlete’s damaged knee joints. But cell therapies are ”living medicines” for which the positive impact on patients is limited by critical bottlenecks in the manufacturing of even approved biopharmaceutical therapies. All cell therapies begin with a human donating the cells that will be manufactured into medicine, and that is just the start of the manufacturing complexities when biology (rather than just chemistry) is used to design and engineer medicine. Here, we will discuss recent advances in the research, development, and workforce training developed by engineers at MIT and our scientific, clinical, and regulatory science partners across the world, including the CAMP (Critical Analytics for Manufacturing Personalized-Medicine) at MIT and in Singapore. These new approaches lay the groundwork for a world that does not just invent exciting new cell therapies, but also produces them in a way that makes the resulting medicine safe, effective, and accessible for each patient.