The Duchossois Family Institute (DFI) at the University of Chicago can manufacture clinical-grade encapsulated bacteria – catalyzing opportunities to better understand the microbiome and its myriad of roles in human health. The first of its kind at an academic institution, the DFI’s current Good Manufacturing Practice (cGMP) facility features bacterial manufacturing capabilities in an anaerobic environment for fermentation, lyophilization, and encapsulation of live biotherapeutic products. “The DFI’s cGMP facility opens opportunities for researchers at the University of Chicago and other institutions to initiate studies using different bacterial consortia designed to treat, prevent, or cure various diseases,” said Eric Pamer, director of the DFI and professor in the departments of medicine, microbiology, and pathology.
“The capacity to manufacture live biotherapeutic products for Phase 1 clinical trials distinguishes the University of Chicago and will lead to microbiome augmentation therapies to improve human health.” The facility features two cleanroom suites, each with monitored and controlled temperature, humidity, differential pressure, and airflow. Equipment has been validated and calibrated for safe, effective, and consistent operation.
A team of dedicated operators, engineers, and scientists ensures safety and aseptic standards, and maintains quality manufacturing processes and unit operation. “The DFI cGMP facility is capable of developing therapeutics.
