ArticleJournal of pharmaceutical sciences2023
Characterization of BNT162b2 mRNA to Evaluate Risk of Off-Target Antigen Translation.
Article in Journal of pharmaceutical sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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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.
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.
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Who cites it
20 citing papers in PubMed.
- Beyond the genetic code: orchestrating epigenetic and immune landscapes with multivalent mRNA-exosome vaccines.Precision clinical medicine · 2026Review
- Advancing Charge Detection Mass Spectrometry for Characterizing Large, Intact mRNA Constructs.Analytical chemistry · 2026Article
- Continuous Purification of mRNA Produced by In Vitro Transcription Using High Performance Countercurrent Membrane Purification.Biotechnology and bioengineering · 2026Article
- A Modular Mechanistic In Silico Model for In Vitro Transcription Process Yield and Product Quality Prediction.Biotechnology and bioengineering · 2026Article
- Analytical Characterization and Stability Assessment of RNA-Based Vaccines.Pharmaceutics · 2026Review
- Establishment and Validation of a Cell-Based Relative Potency Method for Respiratory Syncytial Virus mRNA Vaccine Drug Substance.Vaccines · 2026Article
- Qualification of a quantitative stability indicating potency assay for mRNA-LNP vaccine candidates.Gates open research · 2026Article
- mRNA-based SARS-CoV-2 vaccines: intracellular processing and aggregation of the encoded spike protein as a mechanistic contributor to cardiac cellular stress.Frontiers in immunology · 2026Article
- mRNA vaccines: immunogenicity and quality characteristics.Journal of nanobiotechnology · 2025Review
- Analytical approach for identification and mechanistic insights into mRNA-lipid adduct formation.Molecular therapy. Nucleic acids · 2025Article
- Characterization of intact mRNA-based therapeutics by charge detection mass spectrometry and mass photometry.Molecular therapy. Methods & clinical development · 2025Article
- Current Analytical Strategies for mRNA-Based Therapeutics.Molecules (Basel, Switzerland) · 2025Review
- A Comprehensive Evaluation of Analytical Method Parameters Critical to the Reliable Assessment of Therapeutic mRNA Integrity by Capillary Gel Electrophoresis.Electrophoresis · 2025Article
- Characterisation and analysis of mRNA critical quality attributes using liquid chromatography based methods.Journal of chromatography. A · 2025Review
- A novel in-vitro expression assay by LC/MS/MS enables multi-antigen mRNA vaccine characterization.Scientific reports · 2025Article
- RP-HPLC-CAD method for the rapid analysis of lipids used in lipid nanoparticles derived from dual centrifugation.International journal of pharmaceutics: X · 2024Article
- Development of a capillary zone electrophoresis method to monitor magnesium ion consumption during in vitro transcription for mRNA production.Analytical and bioanalytical chemistry · 2024Article
- Comprehensive Impurity Profiling of mRNA: Evaluating Current Technologies and Advanced Analytical Techniques.Analytical chemistry · 2024Article
- Digital Twin Fundamentals of mRNAACS omega · 2024Article
- Separation of Plasmid DNA Topological Forms, Messenger RNA, and Lipid Nanoparticle Aggregates Using an Ultrawide Pore Size Exclusion Chromatography Column.Analytical chemistry · 2023Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
mRNA vaccines have been established as a safe and effective modality, thanks in large part to the expedited development and approval of COVID-19 vaccines. In addition to the active, full-length mRNA transcript, mRNA fragment species can be present as a byproduct of the cell-free transcription manufacturing process or due to mRNA hydrolysis. In the current study, mRNA fragment species from BNT162b2 mRNA were isolated and characterized. The translational viability of intact and fragmented mRNA species was further explored using orthogonal expression systems to understand the risk of truncated spike protein or off-target antigen translation. The study demonstrates that mRNA fragments are primarily derived from premature transcriptional termination during manufacturing, and only full-length mRNA transcripts are viable for expression of the SARS-CoV-2 spike protein antigen.
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Registered trials
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.