Evidence map›Paper›PMID 38400152›Full record

ArticleVaccines2024

Correlating Stability-Indicating Biochemical and Biophysical Characteristics with In Vitro Cell Potency in mRNA LNP Vaccine.

Xin Tong, Jessica Raffaele, Katrina Feller, Geethanjali Dornadula, James Devlin, David Boyd, John W Loughney, Jon Shanter, Richard R Rustandi

Abstract read
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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

12 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Xin TongAnalytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.ORCID 0000-0003-2200-0899
Jessica RaffaeleAnalytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.ORCID 0000-0002-7405-703X
Katrina FellerAnalytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.
Geethanjali DornadulaAnalytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.
James DevlinAnalytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.
David BoydProcess Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.
John W LoughneyAnalytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.
Jon ShanterProcess Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.
Richard R RustandiAnalytical Research & Development, Merck & Co., Inc., Rahway, NJ 07065, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development of mRNA vaccines has increased rapidly since the COVID-19 pandemic. As one of the critical attributes, understanding mRNA lipid nanoparticle (LNP) stability is critical in the vaccine product development. However, the correlation between LNPs' physiochemical characteristics and their potency still remains unclear. The lack of regulatory guidance on the specifications for mRNA LNPs is also partially due to this underexplored relationship. In this study, we performed a three-month stability study of heat-stressed mRNA LNP samples. The mRNA LNP samples were analyzed for their mRNA degradation, LNP particle sizes, and mRNA encapsulation efficiency. In vitro cell potency was also evaluated and correlated with these above-mentioned physiochemical characterizations. The mRNA degradation-cell potency correlation data showed two distinct regions, indicating a critical cut-off size limit for mRNA degradation. The same temperature dependence was also observed in the LNP size-cell potency correlation.

Indexed as

lipid nanoparticlesmRNA vaccinespotencystability

Identifiers

PMID38400152
PMCPMC10893231

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.