NGS based identity testing for mRNA therapeutics: a GMP workflow for sequence verification

Ensuring reliable mRNA identity verification with Next-Generation Sequencing

mRNA‑based therapeutics are rapidly expanding, driven by their use in vaccines and replacement therapies. Ensuring their safety and efficacy requires rigorous characterisation of several critical quality attributes, including sequence identity.

Traditional approaches provide valuable insights but PCR and restriction mapping only allow partial interrogation of sequence identity, whereas Sanger sequencing remains limited in terms of sensitivity and throughput.

This application note presents a GMP‑validated Illumina NGS workflow that enables full‑length, highly sensitive, sequence‑agnostic identity testing for mRNA‑based products, supporting robust quality assessment in line with evolving regulatory expectations.

Download the complete application below for full experimental details ⬇️

How NGS-based identity testing strengthens your mRNA development strategy?

This NGS workflow provides a complete, high‑resolution approach to verifying mRNA sequence integrity across the entire open reading frame.

• Confirms full‑length identity with complete sequence coverage.
• Detects single‑nucleotide substitutions, insertions and deletions, including low‑frequency variants.
• Eliminates primer design constraints through a fully sequence‑agnostic method.
• Supports potency and quality interpretation by identifying disruptive sequence modifications.
• Delivers high‑quality, compliant data supporting regulated analytical strategies.

NGS and Data Integrity in a regulated environment

Implementing NGS within a GMP environment requires strict control of compliance and data integrity, as most sequencing platforms and bioinformatics tools were not originally designed for pharmaceutical use. We’ve built a fully GMP‑aligned NGS workflow ensuring complete traceability of raw data, metadata and processing steps in accordance with ALCOA++ principles.

Through strong coordination between scientific and technical teams, the workflow ensures that results for mRNA identity testing are generated and reported in line with regulatory expectations, enabling seamless adoption of NGS in regulated development programmes.

Let’s discuss your mRNA identity testing strategy