Evidence map›Paper›PMID 41557011›Full record

ReviewMolecular biology reports2026

Process and analytical strategies for the safe production of mRNA vaccines and therapeutics.

Cinderella J A Nowak, Sha Liu, Robert J Falconer, Lukas Gerstweiler

Abstract readReview
In one paragraph

Review in Molecular biology reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
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  5. Article
  6. 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

4 authors.

Cinderella J A NowakSchool of Chemical Engineering, Faculty of Sciences, Engineering and Technology, Adelaide University, Adelaide, SA, 5005, Australia.ORCID http://orcid.org/0000-0003-2359-5302
Sha LiuSchool of Chemical Engineering, Faculty of Sciences, Engineering and Technology, Adelaide University, Adelaide, SA, 5005, Australia.ORCID http://orcid.org/0000-0003-2890-3247
Robert J FalconerSchool of Chemical Engineering, Faculty of Sciences, Engineering and Technology, Adelaide University, Adelaide, SA, 5005, Australia.ORCID http://orcid.org/0000-0002-9912-9036
Lukas GerstweilerSchool of Chemical Engineering, Faculty of Sciences, Engineering and Technology, Adelaide University, Adelaide, SA, 5005, Australia. lukas.gerstweiler@adelaide.edu.au.ORCID http://orcid.org/0000-0002-2421-5503

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The production of high-purity mRNA drug substances by in vitro transcription utilizing T7 RNA polymerase can be challenging due to the formation of product related impurities. These include double-stranded RNA, fragmented mRNA, and uncapped transcripts. This review examines the known mechanisms underlying the formation of the major mRNA impurities during in vitro transcription (IVT), their biological impact and strategies for their mitigation. Some companies have utilised engineered T7 RNA polymerases and optimized transcription conditions to improve mRNA purity. There is a growing focus on refining upstream and downstream processes to improve mRNA purity. The current analytical approaches for impurity detection and quantification are reviewed. These range from immunological assays to advanced chromatographic and sequencing technologies. Continued innovation is needed to develop the next generation of high-throughput, cost-efficient analytical methods for quantifying mRNA impurities. Together improved transcription, purification and analysis enable the manufacture of safe efficacious mRNA for vaccines and therapeutics.

Indexed as

mRNA VaccinesRNA, MessengerVaccinesDNA-Directed RNA PolymerasesDrug ContaminationHumansTranscription, GeneticViral Proteinsbacteriophage T7 RNA polymeraseDNA-Directed RNA PolymerasesmRNA VaccinesRNA, MessengerVaccinesViral ProteinsBio-manufacturingCritical quality attributesHigh-throughputHPLCImpuritiesIn vitro transcriptionMRNA vaccines/Therapeutics

Identifiers

PMID41557011
PMCPMC12819531

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.