E10i-494
DC13101
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Literature evidence · DC60564
Formulation & Performance
Mouse and nonhuman-primate studies are presented separately, together with particle characterization, cellular observations and stability findings. The supporting information identifies mPEG-DMA in the GVS-18-B6 formulation; it is not automatically interchangeable with DMG-PEG2000.
The named GVS-18-B6 structure is shown in the primary article and supporting information. The catalog formula is C36H71NO3Si. Tissue expression and clearance findings concern formulated RNA delivery, not a guaranteed property of every preparation.
Formulation components and molecular-weight conversion
| Component | DC Chemicals product | Molecular weight | Molar ratio | Mass at 1 µmol total lipid (mg) |
|---|---|---|---|---|
| GVS-18-B6 | DC60564 | 594.05 | 54.6 | Not calculable from disclosed data |
| DSPC | DC57005 | 790.15 | 10.9 | Not calculable from disclosed data |
| Cholesterol | DCD-041 | 386.65 | 32.8 | Not calculable from disclosed data |
| mPEG-DMA | Not uniquely mapped | Not established | 1.6 | Not calculable from disclosed data |
The nominal ratio is from Materials and Methods, LNP Production, in the order GVS-18-B6:DSPC:cholesterol:PEG lipid. Its rounded total is 99.9. SI Table S2 identifies mPEG-DMA and separately reports pre- and post-formulation measurements. PEG molecular weight and exact catalog mapping remain unassigned, so a complete mass conversion is not prefilled. The low-PEG hemolysis formulation is a separate experiment. No N/P value is inferred.
Component mass calculator
Not all inputs are assigned to a single verified study formulation; unassigned fields are blank. Enter your own values to calculate a research scenario. Molecular weights and ratios are editable. Results are calculated, not measured study data. No N/P or RNA dose is inferred.
| Component | MW | Molar ratio | Mass (mg) | Mass % |
|---|---|---|---|---|
| GVS-18-B6 | ||||
| DSPC | ||||
| Cholesterol | ||||
| mPEG-DMA |
Composition and particle properties
| Parameter | GVS-18-B6 result | Source and scope |
|---|---|---|
| Z-average / PDI | 89 nm / 0.06 | Main Table 1 |
| Encapsulation efficiency | 90% | Main Table 1; not a lot-release specification |
| Apparent LNP pKa | 6.15 | Main Table 1; formulation-associated value |
| Zeta potential | 2.69 mV at pH 5.5; 0.98 mV at pH 7.5 | Main Table 1 |
| Measured stock composition | GVS-18-B6:DSPC:cholesterol:mPEG-DMA = 55:11:32:1.5 | SI Table S2; rounded analytical results |
| Measured post-formulation composition | 53:12:33:1.6, in the same component order | SI Table S2; do not silently replace nominal input proportions |
The nominal Methods composition, rounded summary in Results, and Table S2 measurements have distinct meanings and are retained separately.
Mouse expression and inflammatory biomarker comparison
Table 1 reports a matched screening comparison. In the associated mouse expression study, EGFP was measured 24 h after IV EGFP-mRNA LNP administration; plasma MCP-1 was assessed at 6 h. Figure 2 specifies BALB/c mice, n = 3 per group, with SEM.
| Lipid | Liver EGFP: printed 10E7 pg/g column | Spleen EGFP: printed 10E6 pg/g column | Plasma MCP-1 (pg/mL) |
|---|---|---|---|
| GVS-18-B6 | 5.30 | 0.58 | 81 |
| MC3 | 2.07 | 1.10 | 159 |
| Compound 9 / Acuitas A9 | 2.64 | 1.15 | 3152 |
| Moderna Lipid 5 | 0.98 | 0.86 | 190 |
| LP-01 | 1.81 | 0.72 | 140 |
| SM-102 | 1.66 | 0.57 | 107 |
The numerical EGFP entries and printed column headings are retained without reinterpreting the source notation. Liver expression for GVS-18-B6 is approximately 2.56 times MC3 within this table (calculated 5.30/2.07). This is not a cross-study superiority claim.
Cellular trafficking and membrane-assay findings
| Study | Reported observation | Interpretive limit |
|---|---|---|
| HeLa-cell hOTC-mRNA imaging; Figure 4 | GVS-18-B6 showed stronger uptake than Moderna Lipid 5 while retaining reduced endosomal colocalization relative to MC3. | Qualitative microscopy; an exact escape percentage is not supplied. |
| Mouse red-blood-cell assay; SI Figure S3 | At pH 6.2, GVS-18-B6 LNP produced more hemolysis than the two benchmarks. At pH 5.5, all showed high hemolysis. | A membrane-disruption surrogate; this is not a direct clinical hemolysis result or a cell-viability assay. |
| SI hemolysis composition | GVS-18-B6:DSPC:cholesterol:PEG lipid = 55.4:11.1:33.3:0.25. | Distinct low-PEG formulation; do not substitute the nominal expression formulation. |
Primary Results, Figure 4 and SI Figure S3. No cell-viability percentage is inferred from these images.
Mouse clearance and tolerability
The primary article distinguishes the EGFP-mRNA expression study from the higher-dose siRNA tolerability comparison. Negative benchmark findings are not assigned to GVS-18-B6.
| Study | Reported result | Evidence boundary |
|---|---|---|
| Parent-lipid liver clearance; Figure 2 | Almost complete disappearance of GVS-18-B6 from mouse liver within 6 h. | Parent-lipid clearance is not identical to RNA clearance or duration of protein expression. |
| Nonstimulatory-siRNA tolerability; Figure 3 | Little elevation in measured ALT, AST, MCP-1 and IL-6 was reported across the tested doses, up to 6 mg/kg RNA. | Separate siRNA experiment; not proof that every mRNA formulation tolerates the same dose. |
| Study context | BALB/c mice, n = 4 per group; cytokines at 6 h, liver enzymes and weight at 24 h. | Acute readouts; no universal NOAEL or chronic safety margin is assigned. |
Figures 2 and 3; tolerability dose series 1, 2, 4 and 6 mg/kg siRNA. Exact graph-derived biomarker numbers were not digitized.
Cynomolgus-monkey single and repeat administration
| Experiment | Reported result | Context |
|---|---|---|
| Single hOTC-mRNA administration | Strong liver hOTC expression with substantially less in spleen at 24 h. | Figure 5A; 1 mg/kg RNA by 60-min IV infusion. |
| Parent-lipid pharmacokinetics | Plasma half-life approximately 30 min; most parent lipid cleared from liver within 24 h. | Figure 5B–C; parent lipid, not payload. |
| Repeat hEPO-mRNA study | Comparable expression profiles after doses 1 and 5; no significant change suggesting accelerated blood clearance in this experiment. | Figure 5D; 0.25 mg/kg weekly for five administrations. |
| Replication and interpretation | Figure 5 reports n = 3–4 cynomolgus monkeys per group and SEM. | Repeated expression is not proof of absent anti-PEG antibodies or established long-term clinical safety. |
The monkey experiments concern GVS-18-B6. They are not assigned to the A9, MC3 or LP-01 comparison lipids.
Formulated-product stability
| Comparison | Reported finding | Limit |
|---|---|---|
| Storage followed for up to 12 months | Frozen storage at −80 °C best preserved RNA and ionizable-lipid integrity; wet refrigerated or room-temperature preparations degraded over time. | Figure 6; formulation-specific stability, not a shelf life for the supplied neat lipid. |
| Repeated freeze–thaw comparison | The tested formulations retained measured particle attributes and comparable mouse expression after repeated cycles. | Figure 7; the study does not justify unlimited freeze–thaw cycles. |
Storage and freeze–thaw results remain separate from batch storage instructions and commercial retest dates. No synthesis procedure or chemical analytical method is reproduced.
Original study figures
Cellular imaging, mouse expression and tolerability, monkey studies and stability figures — Original source figures.
References and source locations
- Holland R, Lam K, Jeng S, et al. Silicon Ether Ionizable Lipids Enable Potent mRNA Lipid Nanoparticles with Rapid Tissue Clearance. ACS Nano. 2024;18:10374–10387. DOI: 10.1021/acsnano.3c09028. Table 1; Figures 2–7; Materials and Methods.
- Supporting Information, nn3c09028_si_001.pdf. Table S2 (mPEG-DMA and measured composition); Figure S3 (hemolysis); Figure S4 (protein corona).
| CAS No. | Not available |
| Chemical Name | Lipid GVS-18-B6 |
| Synonyms | Lipid GVS 18 B6, GVS-18-B6 |
| SMILES | CCCCC/C=C\CCCO[Si](CCCCN(C)C)(OCCC/C=C\CCCCC)OCCC/C=C\CCCCC |
| Formula | C36H71NO3Si |
| M.Wt | 594.05 |
| Purity | >95% by ELSD-HPLC |
| Storage | Pure form: −20 °C, 1 year; In solvent: −80 °C, 6 months; −20 °C, 1 month. Sealed and protected from light. |
| Shipping condition | Ships from Shanghai. Pure lipid is stable during ice-pack transport. |
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