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mRNA vaccine quality analysis using RNA sequencing

Author

Listed:
  • Helen M. Gunter

    (University of Queensland
    University of Queensland)

  • Senel Idrisoglu

    (University of Queensland
    University of Queensland)

  • Swati Singh

    (University of Queensland
    University of Queensland)

  • Dae Jong Han

    (University of Queensland)

  • Emily Ariens

    (University of Queensland)

  • Jonathan R. Peters

    (University of Queensland)

  • Ted Wong

    (Garvan Institute of Medical Research)

  • Seth W. Cheetham

    (University of Queensland
    University of Queensland)

  • Jun Xu

    (University of Queensland)

  • Subash Kumar Rai

    (University of Queensland)

  • Robert Feldman

    (COVID19 Vaccine Corporation Limited (CVC))

  • Andy Herbert

    (COVID19 Vaccine Corporation Limited (CVC))

  • Esteban Marcellin

    (University of Queensland)

  • Romain Tropee

    (University of Queensland)

  • Trent Munro

    (University of Queensland
    University of Queensland)

  • Tim R. Mercer

    (University of Queensland
    University of Queensland)

Abstract

The success of mRNA vaccines has been realised, in part, by advances in manufacturing that enabled billions of doses to be produced at sufficient quality and safety. However, mRNA vaccines must be rigorously analysed to measure their integrity and detect contaminants that reduce their effectiveness and induce side-effects. Currently, mRNA vaccines and therapies are analysed using a range of time-consuming and costly methods. Here we describe a streamlined method to analyse mRNA vaccines and therapies using long-read nanopore sequencing. Compared to other industry-standard techniques, VAX-seq can comprehensively measure key mRNA vaccine quality attributes, including sequence, length, integrity, and purity. We also show how direct RNA sequencing can analyse mRNA chemistry, including the detection of nucleoside modifications. To support this approach, we provide supporting software to automatically report on mRNA and plasmid template quality and integrity. Given these advantages, we anticipate that RNA sequencing methods, such as VAX-seq, will become central to the development and manufacture of mRNA drugs.

Suggested Citation

  • Helen M. Gunter & Senel Idrisoglu & Swati Singh & Dae Jong Han & Emily Ariens & Jonathan R. Peters & Ted Wong & Seth W. Cheetham & Jun Xu & Subash Kumar Rai & Robert Feldman & Andy Herbert & Esteban M, 2023. "mRNA vaccine quality analysis using RNA sequencing," Nature Communications, Nature, vol. 14(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-41354-y
    DOI: 10.1038/s41467-023-41354-y
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    Cited by:

    1. Xuyang Zhao & Junyao Li & Qingyuan Fan & Jing Dai & Yanping Long & Ronghui Liu & Jixian Zhai & Qing Pan & Yi Li, 2024. "Composite Hedges Nanopores codec system for rapid and portable DNA data readout with high INDEL-Correction," Nature Communications, Nature, vol. 15(1), pages 1-12, December.

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