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Chapter Five

Our Process

From science to product. How we make it.

Two things have to be true every time: the source has to come from a healthy microbiome (rarer than it sounds), and the process has to destroy every living thing in it without destroying the molecules that make it worth taking.

Part One

The Material: Our Donors

The product is only as good as the donor. A compromised microbiome, an undisclosed infection, a dietary pattern that produces dysbiotic metabolites. Any of those would transfer with the material; in 2019, drug-resistant E. coli passed from a single donor to two fecal-transplant recipients [→ DeFilipp 2019].

Our donors are U.S. residents ages 18 to 50. We screen them using a deferral model informed by blood- and tissue-donation safety standards: 67 criteria, 19 of them disqualifying. A physician and a quality-control reviewer must each approve a donor; if they disagree, we do not accept the donor. Approval comes with follow-up: we re-screen donors every six months.

  • 1
    Health and lifestyle questionnaire

    We review a prospective donor's health history, daily habits and potential exposures.

  • 2
    Physician interview

    A physician talks with the prospective donor to put their answers in context, across:

    • ·Cardiovascular and metabolic health
    • ·GI history
    • ·Infectious disease history
    • ·Mental health
    • ·Exercise and dietary habits
    • ·Reproductive health
    • ·Microbiome-specific factors: historical diet, travel, occupational risk, environmental exposures
  • 3
    Blood and stool testing

    Bloodwork: CBC with differential, CMP, lipid panel, HbA1c, HIV 1/2, Hepatitis C, RPR.

    Stool: C. difficile toxins, E. coli Shiga toxins, Salmonella, Shigella, Campylobacter, Cryptosporidium, Cyclospora, Giardia, Ova and Parasites, plus whole-genome microbiome sequencing.

We look for years of stable habits alongside laboratory findings. Heat processing does not remove heavy metals, which is one reason exposure history matters. We do not have a final definition of health, and neither does anyone else. Naturopathic physicians and clinicians focused on functional health have refined ours over years, and we still treat it as a working definition.

We do not screen for or match donors on personality, emotional traits or physical traits.

"The donor program is not a supply chain. It's a scientific criterion. We're looking for people whose microbiomes represent what a healthy microbiome should look like, which is rare."
Andrea McBeth, ND | Founder, Thaena
Deep dive on the blogWhat's in ThaenaBiotic®? The Power of Healthy Poop

Sterilized stool from exceptionally healthy people, and what makes a healthy microbial community worth preserving.

Part Two

The method: sterilization

We use heat sterilization to kill bacteria and fungi. In 2021, an independent lab tested sterilized stool in water from one lot (3H9) using the USP <71> sterility test and found no growth; a companion test confirmed that the material allowed the lab to detect growth. That result covers one lot of that material and does not establish sterility for every lot or for finished capsules. We test finished capsules for microbial counts and specified pathogens as part of routine release testing. The sterility test does not assess viruses or prions, measure endotoxin, or establish removal of RNA or DNA.

Each batch is verified through:

Cycle monitoring

We monitor every sterilization run against its qualified temperature and hold-time settings.

Biological indicators

As part of our sterilization program, an independent laboratory, OHSU, reads biological indicators to confirm that the cycle kills the test organisms.

Testing every finished batch

Eurofins currently tests every finished batch for total aerobic count, yeast and mold, and absence of Salmonella, E. coli, S. aureus and Clostridium spp. under USP <2021>/<2022>, plus arsenic, cadmium, lead and mercury under USP <2232>.

Freeze-drying

We freeze-dry the processed material for shelf stability.

Sterilization is the step that could, in principle, damage the molecules that matter. It doesn't: on an untargeted platform covering 1,043 metabolites, 853 were detected, and every one found in the live starting material was still there after autoclaving and freeze-drying. (See The Solution for that result.) The process leaves no culturable bacteria or fungi and keeps the signals that do the work.

The science was there. The process had to follow.

ThaenaBiotic is one tool in your toolbox.

Not the only one. Just one. If you've made it this far, you have what you need to decide whether the science makes sense to you. The next step is yours.

In 8,225 estimated users tracked post-market, zero serious adverse events have been reported. Full safety record →

Try ThaenaBioticSee the Evidence →
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References

  1. 1DeFilipp Z et al. N Engl J Med. 2019;381(21):2043–2050. PMID 31665575. (drug-resistant E. coli transmitted by fecal microbiota transplant)
  2. 2Element Materials Technology. Certificate of Analysis RP25977, USP <71> sterility, lot 3H9, 2021. (on file)

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. ThaenaBiotic® is a dietary supplement. The research summarized on these pages describes the science behind our approach; it does not describe what ThaenaBiotic does for any person or condition.