TECHNOLOGY

The production platform.Engineered as a system.

Automated equipment, dedicated consumables and hospital implementation — designed together to make FMT capsule production controlled and reproducible.

Our solution: from donor material to clinical-grade FMT capsules produced in hospitals. Hospital FMT laboratory — 1 donor screening, 2 stool collection and testing, 3 patients with unbalanced gut microbiota, 4 capsules stored at −20 °C for up to 3 months. Automated FMT capsule production platform — 6 automated production platform, 7 consumables supplied by technology partners Medesign and Harro Höfliger, 8 long-term storage at −80 °C for up to 4 years.

SETTING: Hospital FMT laboratory
PROCESS: Closed, automated
OUTPUT: Acid-resistant capsules
STATUS: In development

THE WORKFLOW

Five stages.One controlled workflow.

Donor screeningDonors are screened and selected according to clinical guidelines.
Suitable stool donors are screened according to clinical guidelines and approved for donation.
Screening includes
Medical history
Physical examination
Infectious disease testing
Microbiome and virome characterization
Collection & testingStool is collected and tested for pathogens and intestinal health markers.
Stool is collected and tested for pathogens and intestinal health markers before it enters production.
Laboratory testing
Bacterial pathogens
Viral pathogens
Parasites
Blood-borne infections
Additional safety screening
Intestinal health markers (microbiome and virome)
Controlled storage & releaseCapsules are held in quarantine until all test results are approved.
Finished FMT capsules are stored in quarantine for 3 months while all clinical test results are reviewed. After approval, the capsules are released for clinical use.
Quarantine storage
Stored at −80 °C for 3 months while all clinical test results are reviewed
Review of test results
Donor screening results
Infectious disease testing
Microbiological quality control
Product quality testing
All results within specification
Release for clinical use
Stored at −80 °C (up to 2 years) or −20 °C (up to 3 months)
GUT IN BALANCEAutomated processingProcessing and capsule filling in one closed, automated system.
Stool is homogenized, mixed, filtered and dosed in a closed processing bag system and filled directly into capsules using a capsule filling machine.
The process
Processing bag — homogenizing, mixing, filtering and dosing in a closed bag system
Capsule filling — filtered FMT is dosed directly into pH-sensitive capsules
Cooling and collection — filled capsules are cooled to maintain stability
Transfer to −80 °C — capsules move to long-term storage
Hospital storage & useCapsules are stored at −80 °C and used for approved clinical indications.
Standardized FMT capsules are stored at −80 °C in hospital facilities and used for approved clinical indications.
From freezer to patient
Storage — capsules are kept at −80 °C in hospital facilities
Selection — capsules are selected for the specific clinical indication
Administration — the patient takes the capsules orally under clinical supervision
Patient treatment — used for approved indications such as rCDI and AMR
Clinical indications
Recurrent Clostridioides difficile infection (rCDI)
Antibiotic resistant bacteria (AMR)
Other approved indications