Evidence map›Paper›PMID 41957420›Full record

ArticleNPJ vaccines2026

USTAT: Unified Sequential Template Amplification and Transcription-a fully synthetic mRNA manufacturing platform.

Swap Ghosh, Carrie L Simms, Sage D Rohrer, Carlos H Castaneda, Joseph W Saelens, Kaley Niehaus, Michael J Swyers, Joseph Russo

Abstract read
In one paragraph

Article in NPJ vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

8 authors.

Swap GhoshMolecular and Cellular Technologies, Bioprocess R&D, Biotherapeutics Pharmaceutical Sciences, Preclinical & Translational Sciences, Pfizer Inc., Chesterfield, MO, USA.
Carrie L SimmsMolecular and Cellular Technologies, Bioprocess R&D, Biotherapeutics Pharmaceutical Sciences, Preclinical & Translational Sciences, Pfizer Inc., Chesterfield, MO, USA.
Sage D RohrerMolecular and Cellular Technologies, Bioprocess R&D, Biotherapeutics Pharmaceutical Sciences, Preclinical & Translational Sciences, Pfizer Inc., Chesterfield, MO, USA.
Carlos H CastanedaAnalytical R&D, Biotherapeutics Pharmaceutical Sciences, Preclinical & Translational Sciences, Pfizer Inc., Chesterfield, MO, USA.
Joseph W SaelensMachine Learning and Computational Sciences, Preclinical & Translational Sciences, Pfizer Inc., Cambridge, MA, USA.
Kaley NiehausMolecular and Cellular Technologies, Bioprocess R&D, Biotherapeutics Pharmaceutical Sciences, Preclinical & Translational Sciences, Pfizer Inc., Chesterfield, MO, USA.
Michael J SwyersMolecular and Cellular Technologies, Bioprocess R&D, Biotherapeutics Pharmaceutical Sciences, Preclinical & Translational Sciences, Pfizer Inc., Chesterfield, MO, USA.
Joseph RussoMolecular and Cellular Technologies, Bioprocess R&D, Biotherapeutics Pharmaceutical Sciences, Preclinical & Translational Sciences, Pfizer Inc., Chesterfield, MO, USA. Joseph.Russo@pfizer.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

mRNA vaccines have emerged as a transformative modality for infectious disease prevention. In response to the emergence of SARS-CoV-2, large-scale in vitro transcription (IVT) of mRNA vaccines was developed. Large-scale IVT currently relies on linearized plasmid DNA (pDNA) as a template for mRNA production. Linearized pDNA production presents several challenges at manufacturing scale, including removal of residual host-cell DNA, protein, endotoxins, and antibiotics. Additionally, pDNA-derived sequences irrelevant to mRNA production must be removed from the final product. Finally, the generation of linear pDNA template is laborious, which reduces mRNA production speed, a renowned advantage of this technology. Enzymatic DNA amplification strategies such as rolling circle amplification (RCA) of a synthetic circular DNA molecule offer a rapid, isothermal reaction as an alternative to pDNA. Therefore, we have developed a fully synthetic, single-vessel mRNA manufacturing platform. Beginning with a chemically synthesized circular DNA template, we amplify via a fit-for-purpose RCA, linearize with a TypeIIS restriction enzyme (RE), and perform IVT in a single vessel. The entire process-from circular template to mRNA-can be completed in as little as two days. This method, termed Unified Sequential Template Amplification and Transcription (USTAT), eliminates bacterial components, large volume pDNA production, and enables rapid, modular mRNA production.

Identifiers

PMID41957420
PMCPMC13246738

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Registered trials

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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.