In 2023, the DFI completed construction of a current Good Manufacturing Practices (cGMP) facility to manufacture live biotherapeutic products for clinical trials of microbiome optimization at the University of Chicago Medical Center. The DFI’s cGMP facility will enable University of Chicago investigators to translate laboratory discoveries into novel clinical therapies. The facility consists of two fully isolated and equipped cleanroom suites. Within each cleanroom suite temperature, humidity, differential pressure, and airflow are monitored and controlled. Equipment used for manufacturing processes, including fermentation, buffer exchange, lyophilization, and capsule generation is maintained, validated, and calibrated at specified intervals for safe, effective, and consistent operation. A team of dedicated operators, engineers, and scientists have been trained for their respective functions in areas of safety, aseptic standards, manufacturing processes, and unit operation performance within the cGMP facility.
Inquiries regarding the facility should be directed to Eric Pamer.
