UChicago Expands Microbiome Research Capabilities with New Manufacturing Facility
The current Good Manufacturing Practices Facility at the University of Chicago’s Duchossois Family Institute features anaerobic chambers for growing bacteria, seen here.
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.
// About the Duchossois Family Institute
The Duchossois Family Institute: Harnessing the Microbiome and Immunity for Human Health was established on May 24, 2017, with a $100 million gift from Janet and Craig Duchossois and The Duchossois Family Foundation. The DFI aims to maximize good health and the economic, social, and personal benefits it delivers. Together with the Polsky Center, they will bring breakthroughs to market through industry partnerships.
// About the University of Chicago Medical Center
The University of Chicago Medicine, with a history dating to 1927, is a not-for-profit academic health system based on the campus of the University of Chicago in the city’s South Side, with hospitals, outpatient clinics and physician practices throughout Chicago and its suburbs and in Northwest Indiana. UChicago Medicine unites five organizations to fulfill its tripartite mission of research, medical education and patient care: Biological Sciences Division, Pritzker School of Medicine, University of Chicago Medical Center (flagship for the health system), Community Health and Hospital Division, and UChicago Medicine Physicians. For more information about UChicago Medicine, visit uchicagomedicine.org/about-us.