Clinical-grade microbiome drug manufacturing facility opens at UChicago

The Duchossois Family Institute (DFI) at the University of Chicago has opened a new facility equipped to manufacture clinical-grade microbiome therapeutics, catalyzing opportunities for researchers to better understand the microbiome and its myriad roles in human health.

The first of its kind at an academic institution, the facility gives experts the capability to grow, freeze-dry and encapsulate live bacteria into capsules that can be administered safely to patients in clinical trials.

“Across multiple studies in areas ranging from respiratory failure to heart and liver transplant, a broad theme has emerged: losses of the gut microbiome — and the chemicals those bacteria produce — are associated with poor health outcomes, such as infections and longer hospital stays,” said Matthew Odenwald, MD, PhD, a hepatologist at the University of Chicago Medicine whose research focuses on the gut microbiome. “But it’s been a persistent challenge in the microbiome research field to find out whether these associations actually involve causation. That’s where the new manufacturing facility comes in.”

The facility has all the necessary equipment, materials and procedures in place to be compliant with current Good Manufacturing Practices (cGMP): the FDA’s highest regulatory standard for pharmaceutical and biological production. Validated, cutting-edge technology and equipment are precisely calibrated and housed in two cleanroom suites, each with monitored and controlled temperature, humidity, differential pressure and airflow. Teams of dedicated operators, engineers and scientists have been hired in areas of safety, aseptic standards, manufacturing processes and unit operation.

“Operating in a cGMP facility allows us — and the FDA — to be confident that every therapeutic product is as safe as it could possibly be before we give it to a human patient,” Odenwald said.

Research groups across the university and medical center, along with external collaborators, will leverage the cGMP facility to test different associations involving the microbiome, finally allowing them to tease apart correlation and causation in this key area.

These efforts will be aided by existing DFI capabilities in metabolomics, metagenomics and bioinformatics. The Symbiotic Bacterial Strain Bank, which contains almost 2,000 bacterial isolates obtained from healthy human donors, will serve as a source of invaluable knowledge as well as bacteria that will be used for manufacturing.

An investigator-initiated, interventional clinical trial led by researchers at UChicago Medicine and the DFI recently received IND authorization from the FDA and approval from the UChicago IRB, and is expected to begin enrolling patients later in 2024. As part of the trial, the cGMP facility will manufacture capsules containing different combinations of 17 bacteria strains to restore the microbiomes of patients with liver disease.

“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, MD, 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.”