Tianyi Health Tech
AKM Lab-01 · Pasteurized freeze-dried powder · Strain deposit DSM 35743
Tianyi Health Tech supplies bulk pasteurized Akkermansia muciniphila to supplement brands, private-label manufacturers and functional food companies, with OEM/ODM support and a COA for every batch. The ingredient is AKM Lab-01, a heat-inactivated, freeze-dried powder developed and manufactured by our strain partner Moon (Guangzhou) Biotech Co., Ltd. and supplied in 2×1011 and 1×1012 TFU/g grades. If you need the powder-level detail (limits, stability, handling), see our bulk Akkermansia powder specifications.
Specification
| Parameter | Specification | Method / note |
|---|---|---|
| Identity | ||
| Product | Pasteurized (heat-inactivated) freeze-dried Akkermansia muciniphila powder | |
| Strain | AKM Lab-01 (internal code MNH19250) | |
| Strain deposits | DSM 35743 · CGMCC 46611 · GDMCC 63782 | Depositor: Moon (Guangzhou) Biotech |
| Developer and manufacturer | Moon (Guangzhou) Biotech Co., Ltd. (strain partner); supplied by Tianyi | |
| Potency and markers | ||
| Total cells | Specified range 1.0×1011 to 1.0×1012 TFU/g; featured grades 2.0×1011 and 1.0×1012 TFU/g | In-house total-cell SOP (MOA-UN-110) |
| Culturable count | < 10 CFU/g (heat-inactivated) | In-house SOP (MOA-UN-117) |
| Amuc_1100 in total protein | > 60 ng/mg | MS MRM quantification (MOA-UN-119) |
| Species identification | 16S rRNA > 99% identity to A. muciniphila ATCC BAA-835 | MOA-UN-029 |
| Supply | ||
| Formats | Powder, capsules, tablets, gummies, liquids, solid beverages | |
| Shelf life / storage | 36 months; sealed, room temperature | Spec SP-FP-104 v04 |
| Regulatory position | Self-affirmed GRAS conclusion by an independent expert panel (2025). Not an FDA approval. | |
| Documents | Specification sheet, batch COA and technical documents on request | |
Limits are from the manufacturer’s specification sheet SP-FP-104 (v04). The batch COA supplied with each order prevails. The product is pasteurized (heat-inactivated).
Research
The species. Akkermansia muciniphila is a mucin-associated bacterium of the human gut and one of the most studied “next-generation” microbiome ingredients. It is a category of growing interest for gut-barrier and metabolic-health product concepts.
Why pasteurized. Heat-inactivated cells are stable at room temperature, need no cold chain and do not depend on survival through processing, which makes capsules, stick packs, gummies and beverages far easier to formulate than with a living culture. Compare formulation and regulatory differences in our guide: Pasteurized vs. Live Akkermansia: What Formulators Should Know. A randomized, placebo-controlled pilot study of A. muciniphila, including a pasteurized form (a different strain from ours), examined safety, tolerability and metabolic parameters in volunteers (Depommier et al., 2019, reference 1).
Marker proteins & biology. AKM Lab-01 is characterized by three outer-membrane or secreted proteins that are studied for gut-barrier and metabolic signalling: Amuc_1100, P9 (Amuc_1631) and Amuc_1409. Amuc_1100 is described as heat-stable, so it is retained after pasteurization, and every batch is released against an Amuc_1100 content of more than 60 ng/mg of total protein by mass-spectrometry quantification. For an overview of the science, potency metrics and regulatory background, read our explainer: What Is Pasteurized Akkermansia Muciniphila?.
Strain research. AKM Lab-01 was selected from 222 Akkermansia strains isolated from healthy human feces. Its published research to date is preclinical (diet-induced obese mouse models, plus a 90-day mouse safety study), see references 2 and 3. Human research is at an early stage: an internal 3-month pilot study (n=16, single-arm, no placebo) has been completed, and two registered clinical trials, NCT06974266 and NCT07331974, are ongoing research. We draw no efficacy claims from any of these.
Selected references
Guide
AKM Lab-01 is used in capsules, tablets, stick packs, gummies, liquids and solid beverages. It is compatible with plant extracts, vitamins and minerals, collagen and fish or krill oil. We also pair it with our golden dark tea extract for two-ingredient concepts.
We give no recommended serving. For context only: our internal pilot used 3×1010 TFU per day, the independent GRAS panel’s conclusion is up to 3.4×1010 cells per day for conventional foods and beverages, and the EFSA opinion on the pasteurized category refers to 3.4×1010 AFU per day. Define your serving with your regulatory advisor.
Describe it as “pasteurized Akkermansia muciniphila”. Do not use “live” or probiotic CFU wording. Structure/function statements need the standard DSHEA disclaimer and FDA notification, and no disease statements. The GRAS panel conclusion covers conventional foods and beverages, so check new-dietary-ingredient requirements for supplements.
Only authorized health claims may be used and none is authorized for A. muciniphila. Product use must follow the conditions of the novel food authorization, so confirm conformity of AKM Lab-01 with it before launch (see the FAQ).
Market positioning we see from brand customers includes metabolic-health and GLP-1 companion formulas, gut-health lines and combination products. These are market directions, not effect claims about our ingredient.
OEM / ODM
Why Tianyi
We work with Moon Biotech, who developed AKM Lab-01 and runs the production line, so technical and documentation questions get first-hand answers.
Specification sheet and batch COA on request, with total-cell, culturable-count, Amuc_1100, heavy-metal and microbiology results.
Tianyi brings 20+ years of research experience and 11 invention patents at company level, with a scientific network spanning universities and biotech partners.
A named export contact, replies within 24 hours and formulation guidance.
Quality
AKM Lab-01 is manufactured by our strain partner Moon (Guangzhou) Biotech Co., Ltd. under an FSSC 22000 certificate (SGS, scope as printed on the certificate) and carries an International Halal certificate. Moon Biotech is registered as a food facility with the US FDA (registration is not an FDA approval), holds the independent-panel self-affirmed GRAS conclusion, and has deposited the strain at DSMZ (DSM 35743), CGMCC (CGMCC 46611) and GDMCC (GDMCC 63782). It holds 8 granted patents (CN & HK) for strain AKM Lab-01 and Amuc_1100 methods, with further applications pending. These certificates belong to the partner, not to Tianyi. Numbers, scopes and validity dates are listed on Quality & Certifications. If you are auditing ingredient suppliers, review our checklist: How to Choose an Akkermansia Supplier.
More ingredients
FAQ
No. AKM Lab-01 is pasteurized (heat-inactivated) and freeze-dried, so it is supplied as a postbiotic-style ingredient rather than a living-bacteria product. The specification limits the culturable count to below 10 CFU/g and the potency is expressed as total cells in TFU/g (total fluorescent units), not as a probiotic CFU count. Read our technical comparison: Pasteurized vs Live Akkermansia.
We feature 2.0×1011 TFU/g and 1.0×1012 TFU/g, within a specification range of 1.0×1011 to 1.0×1012 TFU/g. See the bulk Akkermansia powder specifications for the full grade and limit tables.
The manufacturer holds a self-affirmed GRAS conclusion issued by an independent expert panel (signed 30 April 2025) for pasteurized Akkermansia muciniphila AKM Lab-01 in conventional foods and beverages, at up to 3.4×1010 cells per day across all food categories combined. This is a panel conclusion, not an FDA GRAS notice, and it is not an FDA approval. For dietary supplements, confirm new-dietary-ingredient requirements with your regulatory advisor.
Pasteurized Akkermansia muciniphila as a category has a positive EFSA safety opinion (2021) and an EU novel food authorization (Commission Implementing Regulation (EU) 2022/168). That authorization was granted on another applicant’s dossier. We do not claim that AKM Lab-01 itself is EU-authorized; whether it can be placed on the EU market under that authorization depends on its conformity with the authorized specification and conditions of use, which your regulatory advisor should confirm.
AKM Lab-01 is developed and manufactured by our strain partner Moon (Guangzhou) Biotech Co., Ltd., and Tianyi supplies it. The FSSC 22000, Halal, FDA facility registration, GRAS conclusion, strain deposits and patents belong to Moon Biotech, not to Tianyi. Details, numbers and validity dates are on the quality and certifications page.
We do not make efficacy claims. An internal 3-month pilot study (n=16, single-arm, no placebo) has been completed, and two clinical trials are registered as ongoing research: NCT06974266 and NCT07331974. Published peer-reviewed work on AKM Lab-01 to date is preclinical (mouse studies).
The specification gives a 36-month shelf life. Store sealed at room temperature, away from toxic, odorous, volatile or corrosive goods, and off the floor and walls. No cold chain is required.
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Last updated: 13 October 2026
Research and clinical information is provided for R&D and B2B reference only. These statements have not been evaluated by the Food and Drug Administration. Our ingredients are not intended to diagnose, treat, cure or prevent any disease. Final specifications and regulatory status are confirmed per commercial agreement.
