Through our partnership with the University of Minnesota Microbiota Therapeutics Program, we have created the only academic stool donor program and microbiota therapeutics manufacturing program in the world. Our microbiota therapeutics processing and manufacturing facility is held to the highest GMP (Good Manufacturing Practice) protocols and is closely regulated by the Federal Drug Administration to ensure the safety and efficacy of our therapeutics. The therapeutics we manufacture are used to treat patients with recurrent C. difficile Infections and target a variety of health conditions in clinical trials around the United States. Learn more about our research indications.
Donor Screening:
- Potential donors complete extensive questionnaires detailing health and infectious risk.
- Qualified individuals receive comprehensive physical examination and testing.
- Laboratory testing assess infectious risk (including COVID-19), metabolic health, and immune status. 13% of donor applicants meet the stringent donor requirements.
- Approved donors maintain health logs and receive COVID-19 testing every two weeks.
- Donor health is assessed with every visit and a full examination is completed every three months.
Donation Process:
- Active donors complete the donation process in a sterile bathroom at the University of Minnesota.
- Stool is collected into a clean container and chilled.
- Donor material is transported in coolers to the GMP facility for manufacturing within four hours.
Manufacturing Process:
- The material is processed to separate the microbiota from the rest of the fecal material.
- The microbiota is further cryopreserved and freeze-dried for encapsulation.
- Each donation is tested to ensure absence of any infectious organisms.
- Microbiota can be released only after all the clinical data and lab tests have been reviewed and verified to satisfaction.
