Screened, tested, held, then released.
Every lot of Novel Biome product moves through the same documented stages under our Health Canada Drug Establishment Licence. Nothing ships until every stage is complete. Screened donors also form the pool for precision donor matching.
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From donor to released lot.
Testing parameters, exclusion criteria and release specifications are provided to registered practitioners for their own review.
Donor assessment
Medical history, lifestyle and medication review against written exclusion criteria. Donors are 10 to 30 years old at enrolment.
Stool screening
Stool testing comes first, so unsuitable donors are identified early. [verify: 44 infectious disease markers per Form 701C v3, Shaina to confirm count and public wording]
Blood and urine panels
Blood and urine panels at intake, then then retested every 90 days.
Quarantine
Material is held for a 90-day quarantine until the applicable testing cycle is complete.
Finished product testing
Each lot is tested in our own laboratory under GLP practice before it can be released.
Release & cold chain
Released against specification, then manufactured for a named patient and shipped cold chain.
Screened for safety. Matched to each patient.
Screening makes a donor safe. Matching makes a donor a fit. Our proprietary donor matching algorithm matches each patient’s baseline sequencing to a donor from the screened pool, instead of the one-size-fits-all approach of conventional FMT.
Only screened donors
Only donors who have passed every screening round above enter the matching pool.
Precision matching
Each patient is matched to a donor using our proprietary algorithm, built on current microbiome science and designed for the best possible match.
Matched, then released
The matched donor’s material is manufactured for the named patient and released against specification like every other lot.
The figures behind the process.
infectious disease markers in donor blood, urine and stool testing
donor retesting interval
quarantine before release
donor age in years at enrolment
Retesting, quarantine and donor age confirmed by Jason. The marker count still needs Shaina’s sign-off.
Documentation you can download.
Licence documents are public. Detailed specifications open after registration.
Health Canada Drug Establishment Licence
Canada’s first DEL issued to a human FMT manufacturer.
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GMP and GLP statement
How our manufacturing and laboratory practice are organized. [verify: which certificates exist and can be shared]
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Screening parameters & release specifications
Full donor exclusion criteria, test panels and lot release specifications.
Questions about donors or quality?
Talk through a case or the protocol with our team.