ArticleGates open research2026
Qualification of a quantitative stability indicating potency assay for mRNA-LNP vaccine candidates.
Article in Gates open research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Potency assays assess the functional integrity of a target antigen to ensure that the final drug product is consistent between the commercial and clinical trial lots. Existing mRNA-LNP vaccine potency assays require complex quantification methods, such as flow cytometry, which are not widely adaptable to routine use by low- and middle-income country (LMIC) manufacturers or National Regulatory Agency (NRA) laboratories. To address the need for more accessible mRNA-LNP vaccine potency methods, an enzyme-linked immunosorbent assay (ELISA) was developed to quantify the target proteins produced by an mRNA-LNP vaccine after cell transfection. SARS-CoV-2 mRNA-LNP targeting the wild-type (Wuhan) strain was used as a model vaccine for the development and qualification of an ELISA method. The adaptability of the ELISA to other mRNA-LNP vaccines was demonstrated by altering the method used for quantification of a commercial Omicron mRNA-LNP vaccine. Alternative mRNA-LNP potency methods, such as western blotting, fluorescence focus assay (FFA), and direct ELISA were used as analogous methods for comparison. The developed quantitative stability-indicating ELISA is a globally accessible potency method that utilizes existing equipment and knowledge. Testing conducted on wild type SARS CoV-2 and Omicron vaccines demonstrates the adaptability of the method to other mRNA vaccine targets.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.