Because you can’t afford to get it wrong…  patients matter

Sequence confirmation is a critical activity during mRNA therapeutic and vaccine manufacturing, both during plasmid production and mRNA identity testing. Sanger sequencing provides the accuracy, workflow simplicity, scalability, and reproducibility to help ensure testing consistency and final product safety.

Role of Sanger sequencing in mRNA vaccine manufacturing

Although the mRNA vaccine production process is straightforward, accuracy is required for the many steps in which DNA and RNA intermediates are manipulated. Therefore, confirming that plasmids and mRNA do not contain unanticipated sequence changes is critical to helping ensure functionality and expected outcomes. Sanger sequencing offers several key attributes for sequence verification:

  Simple workflow
 Rapid time to results
 Unambiguous results
  Scalable workflow
Manufacturing workflow

Identity testing using Sanger sequencing

Thermo Fisher Scientific has developed a streamlined protocol for the sequencing of mRNA without the need for PCR amplification prior to cycle sequencing, thereby shortening time to results while helping reduce the potential for errors.

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SeqStudio Flex: a genetic analyzer suited for mRNA QC

The SeqStudio Flex Series genetic analyzers are our most advanced mid-throughput genetic analyzers with the flexibility, usability, connectivity, and serviceability to keep your QC laboratory up and running at maximum efficiency.  SeqStudio Flex analyzers support 21 CFR Part 11 compliance and have optional security, audit, and electronic signature (SAE) software for an electronic chain of custody, facilitating integration into your GMP laboratory.

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Explore our webinar highlighting highly accurate plasmid verification and mRNA QC

  • Discuss why sequence confirmation is important throughout the manufacturing continuum
  • Address key considerations in selecting a sequence analysis method
  • Discover mRNA identity testing workflows for vaccine QC

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Count on a partner that knows the way

Discover all the Thermo Fisher Scientific products designed to support your mRNA manufacturing needs from plasmid production to formulation, fill, and finish.

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