Evidence map›Paper›PMID 36298569›Full record

ArticleVaccines2022

Rapid Identity and Quantity CQA Test for Multivalent mRNA Drug Product Formulations.

Rachel Y Gao, Christine M Riley, Evan Toth, Rebecca H Blair, Megan N Gerold, Caitlin McCormick, Amber W Taylor, Tianjing Hu, Kathy L Rowlen, Erica D Dawson

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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

10 authors at 1 institution in 1 country.

Rachel Y GaoInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Christine M RileyInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Evan TothInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Rebecca H BlairInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Megan N GeroldInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Caitlin McCormickInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Amber W TaylorInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.ORCID 0000-0002-4402-4608
Tianjing HuInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Kathy L RowlenInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
Erica D DawsonInDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
InDevR (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The COVID-19 pandemic highlighted mRNA as a promising platform for vaccines and therapeutics. Many of the analytical tools used to characterize the critical quality attributes of mRNA are inherently singleplex and are not necessarily optimal from a labor and cost perspective. Here, we demonstrate the feasibility of a multiplexed platform (VaxArray) for efficient identity verification and concentration determination for both monovalent and multivalent mRNA formulations. A model system comprising mRNA constructs for influenza hemagglutinin and neuraminidase was used to characterize the analytical performance metrics for a VaxArray mRNA assay. The assay presented herein had a time to result of less than 2 h, required no PCR-based amplification nor extraction of mRNA from lipid nanoparticles, and exhibited high construct specificity that enabled application to the bivalent mixture. The sensitivity for influenza hemagglutinin and neuraminidase mRNA was sub-µg/mL, which is vaccine-relevant, and the average accuracy (%recovery of a check standard) and precision were 104 ± 2% and 9 ± 2%, respectively.

Indexed as

CQAinfluenzalipid nanoparticlemRNA vaccinemultiplexednucleic acid microarrayVaxArray

Identifiers

PMID36298569
PMCPMC9612012
OpenAlexW4306155920

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.