Evidence map›Paper›PMID 37515040›Full record

ArticleVaccines2023

Development and Characterization of an In Vitro Cell-Based Assay to Predict Potency of mRNA-LNP-Based Vaccines.

Nisarg Patel, Zach Davis, Carl Hofmann, Josef Vlasak, John W Loughney, Pete DePhillips, Malini Mukherjee

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 32 citations in OpenAlex.

  1. pSIM: A next generationMolecular therapy. Advances · 2026
    Article
  2. New approach methodologies (NAMs) for preclinical and translational evaluation of mRNA-lipid nanoparticle (LNP) therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2026
    Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Challenges in Measuring In Vitro Activity of LNP-mRNA Therapeutics.International journal of molecular sciences · 2025
    Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
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  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Nisarg PatelAnalytical Research & Development, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486, USA.ORCID 0009-0005-7850-7420
Zach DavisAnalytical Research & Development, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486, USA.
Carl HofmannAnalytical Research & Development, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486, USA.
Josef VlasakAnalytical Research & Development, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486, USA.
John W LoughneyAnalytical Research & Development, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486, USA.
Pete DePhillipsAnalytical Research & Development, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486, USA.
Malini MukherjeeAnalytical Research & Development, Merck & Co., Inc., 770 Sumneytown Pike, West Point, PA 19486, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Messenger RNA (mRNA) vaccines have emerged as a flexible platform for vaccine development. The evolution of lipid nanoparticles as effective delivery vehicles for modified mRNA encoding vaccine antigens was demonstrated by the response to the COVID-19 pandemic. The ability to rapidly develop effective SARS-CoV-2 vaccines from the spike protein genome, and to then manufacture multibillions of doses per year was an extraordinary achievement and a vaccine milestone. Further development and application of this platform for additional pathogens is clearly of interest. This comes with the associated need for new analytical tools that can accurately predict the performance of these mRNA vaccine candidates and tie them to an immune response expected in humans. Described here is the development and characterization of an imaging based in vitro assay able to quantitate transgene protein expression efficiency, with utility to measure lipid nanoparticles (LNP)-encapsulated mRNA vaccine potency, efficacy, and stability. Multiple biologically relevant adherent cell lines were screened to identify a suitable cell substrate capable of providing a wide dose-response curve and dynamic range. Biologically relevant assay attributes were examined and optimized, including cell monolayer morphology, antigen expression kinetics, and assay sensitivity to LNP properties, such as polyethylene glycol-lipid (or PEG-lipid) composition, mRNA mass, and LNP size. Collectively, this study presents a strategy to quickly optimize and develop a robust cell-based potency assay for the development of future mRNA-based vaccines.

Indexed as

bioassaysLNPmRNApotencypotency assaysvaccines

Identifiers

PMID37515040
PMCPMC10383996
OpenAlexW4383909048

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.