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MRNA / LNP / RESEARCH LIBRARY
Important mRNA/LNP publications from the past 120 days
Search bilingual publication guides on delivery, in vivo CAR-T, therapeutic translation, safety, analytics, and manufacturing.
This CMC review connects lipid chemistry and manufacturing parameters with critical quality attributes in mRNA-LNP development. It compares microfluidic scale-out with impinging-jet scale-up and emphasizes orthogonal analytics, stability in plasma or serum, lipid impurities, and RNA–lipid adducts. Early comparability planning is recommended. The framework does not demonstrate that one carrier or manufacturing platform is universally superior.
Placenta-tropic LNPs produced strong circular-RNA expression in cultured trophoblasts but weaker translation in pregnant mice than linear mRNA. Researchers identified innate immune signaling as a constraint and increased placental expression by inhibiting IFNAR-JAK-STAT pathways. VEGF-encoding cargos provided a therapeutic-payload demonstration. Immune suppression during pregnancy raises separate safety questions that expression improvements alone cannot resolve.
Molecular simulations examined how ionizable lipid nanoparticles interact with endosomal membranes and release nucleic acids. The authors identified several fusion routes, with a stalk-pore pathway predominating, and linked release to protonation, lipid geometry, membrane tension, and cargo organization. The simplified nucleic acid model used short double-stranded DNA, so findings require validation with therapeutic-length RNA.
A polymer-lipid carrier incorporating arginine-modified oligoethylenimine combined T-cell activation with mRNA delivery without an added targeting ligand. The formulation favored splenic delivery and engaged PI3K-AKT-mTOR signaling. FAP-CAR mRNA generated functional CAR T cells in experimental cancer and fibrosis settings. These are preclinical results; the article also has a subsequent publisher correction that should accompany interpretation.
A 40-member retinoic-acid-derived ionizable-lipid library yielded AT4-13CRA particles with preferential functional expression in splenic antigen-presenting cells. Researchers linked delivery to altered protein coronas and reduced lysosomal retention. An ovalbumin vaccination model showed stronger antigen-specific immunity and prophylactic tumor protection. The artificial antigen and challenge setting limit direct extrapolation to established human cancers.
FDA approved MFLUSIVA, an mRNA influenza vaccine for adults 50 and older. Ages 50–64 received traditional approval based on clinical efficacy evidence; ages 65 and older received accelerated approval based on antibody responses versus a high-dose comparator, requiring confirmation of clinical benefit. FDA’s review reports overall relative vaccine efficacy of 26.6% versus a standard-dose comparator in the Phase 3 P304 trial.
A mannose-containing fifth lipid was incorporated into spleen-targeted LNPs to combine endogenous organ enrichment with receptor-associated uptake. Adjusting mannose-lipid content shifted distribution toward the spleen and improved macrophage transfection. Experiments identified uptake by macrophages and conventional dendritic cells, alongside freeze-thaw stability testing. These findings support immune-delivery development, while therapeutic and human targeting performance remain undetermined.
Anti-CD34-conjugated LNPs delivered reporter mRNA and gene-editing cargos to human hematopoietic stem and progenitor cells. Intrafemoral administration in humanized mice supported durable BCL11A-enhancer editing and fetal hemoglobin reactivation; ELANE editing partially restored neutrophil development in another model. The study addresses difficult stem-cell targeting but uses a specialized administration route and preclinical systems.
This review compares liquid chromatography and mass spectrometry strategies for quantifying ionizable lipids, PEG lipids, helper phospholipids, cholesterol, and degradation products in mRNA-LNP formulations. It considers sensitivity, linearity, run time, matrix effects, and stability-indicating measurements. The comparison supports method selection rather than demonstrating a single validated release assay applicable to every formulation.
Moderna reported that its Phase 3 safety and efficacy trial of the norovirus vaccine candidate mRNA-1403 did not meet the statistical criteria for early success at an interim analysis. The study remains ongoing and blinded, and the company is preparing to enroll another cohort. The announcement does not establish the final efficacy result or show that the entire trial has failed.
Researchers identified Klebsiella phage 32 RNA polymerase as an alternative to T7 for RNA production. The enzyme tolerated a broad range of temperatures, pH values, and salt conditions. For an 11,551-nucleotide self-amplifying RNA retaining its native AU initiation, production was 9.3-fold higher than the T7 comparison. These laboratory results do not establish GMP-scale performance.
Comparing intranasal and intratracheal vaccination, researchers found that total lung expression alone poorly predicted functional delivery to alveolar macrophages. Intratracheal mRNA-LNP delivery produced stronger macrophage transfection and antigen presentation, with improved tumor control in pulmonary models. Depleting alveolar macrophages eliminated protection, supporting their mechanistic role. These administration and efficacy findings remain preclinical.
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