Evidence map›Paper›PMID 41150448›Full record

ArticleVaccines2025

Optimization of In Vitro Transcription by Design of Experiment to Achieve High Self-Amplifying RNA Integrity.

Chaoying Hu, Haixin Wang, Guanxing Liu, Kelei Li, Xuanxuan Zhang, Lifang Song, Fan Gao, Xing Wu, Qian Wang, Mingchen Liu and 7 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

17 authors.

Chaoying HuState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Haixin WangBeijing Minhai Biotechnology Co., Ltd., Beijing 102600, China.
Guanxing LiuState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Kelei LiBeijing Minhai Biotechnology Co., Ltd., Beijing 102600, China.
Xuanxuan ZhangState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Lifang SongState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Fan GaoState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Xing WuState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Qian WangState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Mingchen LiuState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Jianyang LiuState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Zhihao FuState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Xiao MaState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Miao XuState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Qunying MaoState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Zhenglun LiangState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.
Qian HeState Key Laboratory of Drug Regulatory Science, Evaluation of Biological Products, Key Laboratory of Research on Quality and Standardization of Biotech Products, Institute of Biological Products, National Institutes for Food and Drug Control, Beijing 102600, China.

Funding

Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences 2023-PT350-01State Key Laboratory of Drug Regulatory Science 2024SKLDRS0205
6 · The paper itself

Abstract

backgroundSelf-amplifying mRNA (saRNA) holds promising application prospects. However, due to the inclusion of a replicase sequence, its extended length leads to premature termination during in vitro transcription (IVT), resulting in poor product integrity. This study aims to optimize the IVT process for saRNA vaccines to enhance integrity, thereby addressing the key challenge in saRNA vaccine manufacturing.

methodGuided by the Quality by Design (QbD) framework, Design of Experiment (DoE) methodology was employed to design diverse combinations of process parameters for IVT reactions. Predictive models were established to identify critical process parameters (CPPs) influencing integrity and yield. An optimized parameter set and process design space, meeting predefined yield and integrity standards, were developed. The impact of integrity on the immunogenicity of saRNA vaccines was further investigated.

resultsMg

conclusionThis study successfully established a multivariate IVT design space fulfilling preset integrity and yield criteria, providing critical data references for the industrialization and quality specification development of saRNA vaccines.

Indexed as

design of experimentdesign spaceintegrityin vitro transcriptionself-amplifying mRNA

Identifiers

PMID41150448
PMCPMC12567852

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.