ArticleMolecular therapy. Methods & clinical development2025
End-to-end characterization of AAV manufacturing process using charge detection mass spectrometry.
Article in Molecular therapy. Methods & clinical development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.
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.
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.
Who cites it
3 citing papers in PubMed.
- Modulating pressure in the Orbitrap improves sensitivity and mass resolution in charge detection mass spectrometry.Nature communications · 2026Article
- Comparative Analysis of rAAV Production from Plasmid-Encoded Versus Chromosomally Integrated rAAV Transgene in HEK293 Cells.International journal of molecular sciences · 2026Article
- Gene therapy for liver diseases: methods, challenges and opportunities.Journal of nanobiotechnology · 2026Review
Corrections and comments
- Erratum issued
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Charge detection mass spectrometry (CD-MS) has previously been shown to be effective for analyzing predominantly clean bulk drug substances and drug products of recombinant adeno-associated virus (rAAV). CD-MS holds potential for assessing and monitoring the quality attributes of rAAV during the manufacturing process, from harvest to drug product. The mass range of rAAV material has been well characterized experimentally by CD-MS to agree with theoretical values for protein and target genome masses. CD-MS measures the charge range derived from native electrospray ionization of rAAV materials. Ions of rAAV can be separated in data processing using both mass and charge characteristics to improve certainty of rAAV analytics. We demonstrate the capabilities of CD-MS analysis for examining in-process samples from the bulk harvest, affinity chromatography, and anion exchange chromatography. Our results show that the harvest material maintains consistent empty/partial/full ratios when compared to the affinity purified sample. Process impurities were detected for each stage of production and compared to current industry standards. We find that CD-MS is highly reproducible and can be used to effectively track the production process from harvest to bulk drug substance, providing quantitative results at each stage.
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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.