UChicago expands microbiome research capabilities with new manufacturing facility

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 for clinical trials unseen at any other academic institution. We look forward to connecting with both academic and commercial partners to develop and manufacture life-saving bacterial consortia,” said Ken Onishi, manager for business development and licensing at the University of Chicago’s Polsky Center for Entrepreneurship and Innovation, which supports technology commercialization and industry partnerships.

The DFI’s first investigator-initiated, interventional clinical trial, in collaboration with clinicians at UChicago Medicine, recently received UChicago IRB approval. As part of this, the cGMP facility will manufacture 17 different bacteria strains for the treatment of patients with liver disease. 

Strong ties with the Medical Center provides patient access for trial enrollment, among other benefits. These connections with cross-campus units, in addition to the DFI’s many resources, uniquely positions the University to deliver the highest quality care and industry-leading research.

Additional DFI capabilities include the Host-Microbe Metabolomics Facility, which uses mass spectrometry to identify metabolites; the Microbiome Metagenomics Facility, which provides state-of-the-art sequencing services; and the Symbiotic Bacterial Strain Bank, which contains almost 2,000 bacterial isolates obtained from healthy human donors. These functions are supported by bioinformaticians who provide comprehensive computational data analyses, including genome assembly and annotation.