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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
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.
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.
mRNA QC analysis using InnoviGene Suite
InnoviGene Suite is used for mRNA QC (quality control) by employing its Sequencing QC and Sequencing Identity modules. These modules allow users to:
- Assess sequence quality—ensure the integrity and accuracy of mRNA sequences by analyzing raw sequencing data
- Detect contaminants—identify potential contaminants or anomalies in mRNA samples
- Confirm sequence identity—verify the identity of the mRNA sequences to ensure they match the expected sequences
- Analyze sequence variants—detect and analyze any sequence variations or mutations within the mRNA
By providing these capabilities, InnoviGene Suite helps maintain high standards of mRNA quality, which is crucial for various research and diagnostic applications.
Learn more about InnoviGene Suite ›
Get a free trial license ›
App Note: Sanger sequencing of plasmid DNA and mRNA analyzed with InnoviGene Suite software ›
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
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.
Style Sheet for Global Design System
For Research Use Only. Not for use in diagnostic procedures.