Table 2
Parameter: Organic phase | Reported procedure / limitation: Lipid components dissolved in ethanol at ionizable lipid:DSPC:cholesterol:PEG-lipid 50:10:38.5:1.5 mol%. | Source: Main Methods: mRNA-LNP production
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ALC-0315 GMP Grade
Literature records
Search the tables and observations reproduced from the product literature guide. Rows may represent measurements, recipes or experimental context; they are not all independent experiments.
Table 2
Parameter: Aqueous phase | Reported procedure / limitation: mRNA at 0.1 mg/mL in 25 mM sodium acetate, pH 5.0. | Source: Main Methods: mRNA-LNP production
Table 2
Parameter: N/P and mixing | Reported procedure / limitation: N/P = 4; Y-shaped microfluidic cartridge; total flow 6 mL/min; aqueous:organic flow ratio 3:1. | Source: Main Methods: mRNA-LNP production
Table 2
Parameter: Purification | Reported procedure / limitation: Three dialysis exchanges against sterile Ca2+/Mg2+-free PBS using a 3.5 kDa MWCO cassette, followed by concentration through a YM30 centrifugal filter. Duration of each dialysis exchange is not specified. | Source: Main Methods: mRNA-LNP production
Table 2
Parameter: Final RNA concentration / excipient | Reported procedure / limitation: 50 µg/mL mRNA, with or without 10% sucrose (w/v); aliquoted for the specified storage conditions. At least two independently prepared batches per LNP type were used. | Source: Main Methods: mRNA-LNP production
Table 2
Parameter: Particle measurements | Reported procedure / limitation: DLS at 25 °C; solvent setting water for PBS or 10% sucrose for sucrose-containing samples. RiboGreen used for RNA concentration and encapsulation. | Source: Main Methods: mRNA-LNP characterization
Table 2
Parameter: Mouse reporter model | Reported procedure / limitation: 7-week-old female BALB/c mice; 1 µg Fluc mRNA in 20 µL, injected into gastrocnemius muscle; reporter readout 24 h later. | Source: Main Methods: Administration of mRNA-LNP to mice; Bioluminescence imaging
Table 2
Parameter: Storage design | Reported procedure / limitation: Aliquoted Fluc mRNA-LNPs at 4 °C or −80 °C; plotted functional tests at weeks 0, 4, 8, 12 and 20. Particle measurements and mouse dosing performed on the same test day. | Source: Fig. 4; Main Methods: mRNA-LNP stability test
Table 3
Measurement / batch: Fresh Fluc-mRNA LNP diameter | Reported result: 90.2 ± 7.8 nm | Evidence context: Main Results; Fig. 1c. Particle-distribution panels represent two experiments, each using two independent LNP preparations.
Table 3
Measurement / batch: Encapsulation efficiency | Reported result: Greater than 95% | Evidence context: Main Results; Fig. 1d; RiboGreen. No precise product-specific mean is invented from the graph.
Table 3
Measurement / batch: PDI / zeta potential | Reported result: No numerical values supplied for these batches in the reviewed article/SI | Evidence context: A broader size-distribution curve is not itself a numerical PDI.
Table 3
Measurement / batch: Apparent pKa cited for the lipid | Reported result: 6.09 | Evidence context: Fig. 1a and Discussion. Imported from the earlier reference cited by the authors; not a newly measured pKa of this experimental batch.
Table 3
Measurement / batch: PBS versus 10% sucrose, short 4 °C condition | Reported result: 83.8 ± 4.6 nm versus 100.1 ± 5.2 nm | Evidence context: Main Results; Fig. 3a
Table 3
Measurement / batch: Sucrose concentration effect | Reported result: Size increase observed between 2% and 10% sucrose; no additional increase reported above 10% | Evidence context: Supplementary Fig. 2. Separate from the fresh Fig. 1 measurement batch.
Table 4
Experiment and dose: Matched intramuscular reporter comparison ALC-0315 LNP versus the other lipid formulations; 1 µg Fluc mRNA in 20 µL IM; female BALB/c mice; n=6/group | Readout and comparator: Readout: 24 h; total photon emission in the injection-site region Comparator: SM-102 and cKK-E12 | Result and source: ALC-0315 and cKK-E12 produced comparable reporter signals. SM-102 mean signal was approximately 60% higher in this matched IM experiment. Fig. 1e–f; mean ± SEM; one-way ANOVA with Tukey comparisons
Table 4
Experiment and dose: Neutralizing-antibody response Spike-antigen mRNA; 1 µg IM per dose on days 1 and 21; n=10/group | Readout and comparator: Readout: Plasma collected days 14 and 35; pseudovirus-neutralization endpoint Comparator: Other ionizable-lipid comparators at the same helper-lipid composition | Result and source: ALC-0315 elicited neutralizing antibodies, with lower titers than SM-102 and cKK-E12 under the matched conditions. All groups increased titers more than 28-fold after boosting. Fig. 2c–f; median Neut50 displayed in violin plots; n=10; no exact Neut50 values extracted
Table 4
Experiment and dose: Inflammatory markers after prime and boost Same IM antigen-mRNA study, 1 µg per dose; n=10/group | Readout and comparator: Readout: Day 2 and day 22, each 24 h after dosing Comparator: Pre-immune plasma and cKK-E12 LNP | Result and source: No significant increase was generally detected for the measured inflammatory panel with SM-102 or ALC-0315 relative to pre-immune plasma. cKK-E12 produced stronger responses for several markers. This is a limited time-point panel, not comprehensive toxicology. Fig. 2b; Supplementary Fig. 1; mean ± SEM
Table 4
Experiment and dose: Sucrose and short freezing exposure ALC-0315 Fluc mRNA-LNP, PBS ±10% sucrose; held 1 h at 4 °C or frozen at −80 °C then thawed | Readout and comparator: Readout: DLS after storage / thawing Comparator: Same LNP without sucrose | Result and source: Sucrose prevented the broad/multiple particle-size peaks observed after freezing and thawing without sucrose. The experiment does not test 20 repeated freeze–thaw cycles. Fig. 3a–b; Supplementary Fig. 2
Table 4
Experiment and dose: Functional delivery after short storage 1 µg Fluc mRNA in 20 µL IM after the Fig. 3 storage conditions; n=5/group | Readout and comparator: Readout: 24 h after injection Comparator: PBS without sucrose and frozen samples with/without sucrose | Result and source: For refrigerated samples, 10% sucrose increased reporter expression by approximately 30–40%; sucrose preserved functional delivery through the tested freezing–thawing exposure. Fig. 3c–f; mean ± SEM; two-way ANOVA with Sidak comparisons
Table 4
Experiment and dose: Long-term formulated-particle storage ALC-0315 Fluc mRNA-LNP at 50 µg/mL; 10% sucrose; 4 °C versus −80 °C; 1 µg IM test dose; n=5/group per functional readout | Readout and comparator: Readout: Weeks 0, 4, 8, 12 and 20; mouse imaging 24 h after each test injection Comparator: Week-0 activity and the other ionizable-lipid formulation | Result and source: ALC-0315 showed a greater relative loss of functional activity than SM-102 at 4 °C. Both developed aggregation around week 8; activity was retained at −80 °C across the tested period. Fig. 4a–d; mean ± SEM; within-group comparisons to week 0
Table 4
Experiment and dose: Encapsulation versus functional stability Same storage study; formulated Fluc mRNA-LNP | Readout and comparator: Readout: Particle/encapsulation monitoring; RNA gel at week 20 Comparator: 4 °C versus −80 °C | Result and source: Encapsulation remained high while refrigerated functional potency declined. Gel analysis showed comparable detectable RNA after 20 weeks at both temperatures; retained encapsulation or RNA band intensity did not guarantee retained delivery activity. Fig. 4b,e; gel representative of two independent LNP preparations