We’re proud to collaborate with our partners at OHMX.bio to introduce a cutting-edge approach to critical quality attribute (CQA) testing for mRNA.
The rise of mRNA-based therapeutics and vaccines has revolutionised the biopharmaceutical industry. However, with innovation comes stringent regulatory oversight. Strict guidelines such as ICH-Q5 and EMA regulations require comprehensive quality control to ensure the safety and efficacy.
Long-read nanopore sequencing
Together with our sister-company OHMX.bio, we’re leveraging long-read nanopore sequencing technology to streamline mRNA CQA testing. This approach enables simultaneous analysis of multiple CQAs in a single sequencing run, dramatically reducing both time and cost:
- Identity: Verifying the mRNA sequence with precision.
- Poly(A)-tail length: Measuring a critical feature for mRNA stability and translation.
- Residual dsRNA: Ensuring safety by identifying unwanted double-stranded RNA.
- Capping efficiency: Evaluating the efficiency of mRNA capping for proper translation.
- Modifications: Confirming critical chemical modifications to enhance mRNA performance.
Meeting regulatory standards with proven technology
To support the development of mRNA therapeutics or vaccines within the framework of European and U.S. guidelines, we are preparing to implement the GMP-compliant Oxford Nanopore Q-line GridION system. This proven, locked-down platform ensures compliance with:
- I21 CFR Part 11 and EU GMP Annex 11 requirements
- ISO 9001:2015-certified manufacturing processes
- Full operating software and consumable version support for three years post-release
Transitioning from research use only (RUO) to GMP-compliant solutions, we will soon offer shorter turn-around-times and standardised reporting for enhanced consistency and regulatory submission readiness.
One-stop solution
By integrating this innovative nanopore sequencing technology into our existing mRNA analytics package, we’re providing a one-stop solution for mRNA quality control. This ensures that as a developer of mRNA therapeutics, you can rely on:
- Drug development support during process development.
- Reliable, accurate data to support regulatory submissions.
- Full operating software and consumable version support for three years post-release
Together with OHMX.bio, we’re bringing speed, precision, and cost-effectiveness to the forefront of mRNA analytics.
