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AMG1541
Formulation & Performance
Formulation & Performance
Study-specific compositions, preparation conditions and experimental outcomes for AMG1541.
Archived full article, full SI and associated source-data files recovered and reviewed. Unresolved source labels are retained as limitations.
1. Formulations and component amounts
Reported composition and calculated mass are separate. Molecular-weight inputs use the current catalog values; DMG-PEG2000 is fixed initially at 2507. Edit inputs only when using a verified alternative material.
AMG1541 / DOPE
mol%SI Table 1
| Component | Molecular weight | Molar parts | Normalized mol% | Amount (µmol) | Weight (mg) |
|---|---|---|---|---|---|
| AMG1541 | 35.000 | 35.5079 | 63.3241 | ||
| DOPE | 16.000 | 16.2322 | 12.0772 | ||
| Cholesterol | 46.500 | 47.1748 | 18.2401 | ||
| DMG-PEG2000 | 2.500 | 2.5363 | 6.3585 |
Calculated total: 100.0000 mg lipid. RNA, solvent and process loss are excluded.
The catalog retains the user-approved 1783.38 input. For C102H186N6O18, the calculated average molecular weight is approximately 1784.63; this basis difference is recorded here and is not silently changed in the product specifications.
How component weights are calculated
For total lipid mass M (mg), molar parts rᵢ and molecular weight MWᵢ: component mass = M × rᵢ × MWᵢ / Σ(r × MW). Component amount (µmol) = component mass (mg) × 1000 / MWᵢ. Molar parts are normalized only for the displayed percentage. The calculation does not infer N/P or RNA dose.
2. Preparation and experimental setup
| Parameter | Reported procedure / limitation | Source |
|---|---|---|
| RNA loading | AMG1541:mRNA 10:1 by mass; reported N/P 11.4:1. | SI Table 1 |
| Lipid stocks | AMG lipid 40 mg/mL in ethanol; helper lipid stocks 10 mg/mL in ethanol. | Main Methods |
| Aqueous phase | mRNA 133 ng/µL in 10 mM citrate, pH 3.0. | Main Methods |
| Microfluidics | Herringbone channel; aqueous:ethanol 3:1; total flow 1.2 mL/min. | Main Methods |
| Comparator context | SM-102 uses DSPC with a 50:10:38.5:1.5 recipe. Lipid chemistry and helper composition therefore both differ in the principal comparison. | SI Table 1 |
3. Particle characterization
| Measurement / batch | Reported result | Evidence context |
|---|---|---|
| Representative AMG1541 batch | Diameter 85 nm; PDI 0.107; encapsulation 67% | SI Table 3; no replicate dispersion supplied in that table |
| Apparent particle pKa | Approximately 6.5, TNS assay | Main / SI characterization |
| RNA protection / storage | Evaluate the particular RNA-loaded formulation and conditions | Not a release specification for neat lipid |
4. Performance by experiment
| Experiment and dose | Readout and comparator | Result and source |
|---|---|---|
| IM reporter expression BALB/cJ mice; Fluc mRNA 1 µg IM | Readout: 6 h Comparator: SM-102 and cKK-E12 study LNPs | Reported expression 3.5-fold above SM-102 and 1.7-fold above cKK-E12. Figure caption states n=3–6; archived source-data entry count requires reconciliation.Fig. 2c; mean ± SD; study ANOVA |
| Off-site liver expression IM Fluc mRNA 1 µg | Readout: 6 h Comparator: SM-102 study LNP | Reported liver expression 8.3-fold lower than SM-102, despite higher injection-site expression. This measures expression, not total particle accumulation.Fig. 2f; comparator-specific n in caption |
| Influenza-antigen dose response HA H3 Tasmania/2020 mRNA; female BALB/cJ mice; 0.01, 0.1 or 1 µg; prime day 0, boost day 21 | Readout: Serum day 35 Comparator: SM-102 LNP | The 0.01 µg AMG1541 arm produced antibody/HAI responses comparable to the 1 µg SM-102 arm under the reported assay. This is not a virus-challenge protection experiment.Vaccine figures; n=5 |
| Sex and strain comparison HA immunization in male/female BALB/c and female C57BL/6 mice | Readout: Day 35 Comparator: Corresponding SM-102 arms | Reported binding-antibody improvements were 15.8-fold, 6.8-fold and 5.8-fold, respectively. These are separate groups rather than one universal fold change.Main vaccine results; n=5 per group |
| Post-boost cytokines HA vaccine study; serum cytokine panel | Readout: 6 h after boost Comparator: SM-102 arms | Most measured cytokines were comparable; female IL-2 was approximately fivefold higher. The data do not support a blanket “no inflammation” statement.Main cytokine results |
| PK identity limitation Muscle lipid measurements in source-data files | Readout: Time-course study Comparator: Related AMG lipids | A source-data label identifies AMG1041 in a context discussed alongside AMG1541. Quantitative AMG1541 clearance values are not assigned from that unresolved table.Fig. 2e source-data label / SI PK methods |
Mechanistic evidence
Hydroxyl-deletion analogs and molecular simulations support a contribution of β-amino alcohols to RNA interactions and delivery. Simulation results and in vivo reporter outcomes are presented as complementary evidence.
5. Interpretation and unresolved details
- A representative 67% encapsulation value is not replaced by a generic >90% claim.
- The Fig. 2c sample count and Fig. 2e lipid identity require reconciliation before independent re-analysis of those raw data.
- The helper-lipid cross-comparisons prevent attributing every formulation difference to ionizable-lipid structure alone.
- Mouse antibody potency does not establish clinical protection or human dose equivalence.
Results apply to the stated LNP composition, cargo, process, dose, route and model. LNP experimental measurements are not batch-release specifications for the isolated lipid.
6. References and data access
Rudra A, Gupta A, Reed K, et al. Degradable cyclic amino alcohol ionizable lipids as vectors for potent influenza mRNA vaccines. Nature Nanotechnology. 2025;20:1831–1842.
DOI: 10.1038/s41565-025-02044-6
Download experiment table (CSV) · Open printable Formulation & Performance guide
Revision FP-20261022 · Source review: 22 October 2026 · DC Chemicals