Oxford Nanopore Technologies (LON: ONT) and Lonza have launched a direct RNA sequencing solution designed for use in GMP-grade quality control testing of mRNA products, completing a development programme that began in early 2024 and represents the first commercially available multi-attribute QC method for mRNA therapies designed to function within a regulated manufacturing environment.
The solution, built on Oxford Nanopore’s direct sequencing technology using its GridION platform, allows multiple critical quality attributes of mRNA products to be assessed simultaneously on a single platform at the same manufacturing site, rather than through the battery of separate analytical methods traditionally required to assess each attribute individually.
Attributes measurable within a single workflow include mRNA identity, integrity, length distribution, poly-A tail length, and capping efficiency, all of which are critical quality parameters for mRNA therapeutics and vaccines that regulators require to be characterised before release.
Lonza has validated the method at its QC laboratories in Geleen, the Netherlands, following pre-validation work at its analytical development facility on the same site, with the workflow now positioned as a component of Lonza’s analytical development offering for biopharmaceutical clients manufacturing mRNA products.
A defining benefit of the platform compared to existing methods is speed: by consolidating multiple analytical readouts onto one technology, the integrated workflow has the potential to reduce testing timelines from weeks to less than a day, a significant competitive advantage in a sector where analytical testing sits on the critical path to batch release and clinical or commercial supply.
Automated data analysis and reporting are built into the system, designed to deliver consistent, QC-ready outputs that support decision-making across the product lifecycle without requiring manual interpretation of complex sequence data.
Sönke Stocker, Executive Director of R&D mRNA and External Innovation at Lonza, said the launch represented an important step forward in how mRNA quality control can be performed, describing the combination of nanopore sequencing with machine learning-based analysis as introducing a simplified multi-attribute approach that better aligns GMP quality control with the pace and complexity of modern mRNA development.
Oxford Nanopore’s direct sequencing technology is the first and only approach capable of reading the native RNA molecule without conversion to DNA, a distinction that provides advantages in detecting chemically modified nucleotides such as N1-Methyl-pseudouridine, which is integral to the design of mRNA vaccines and therapeutics and cannot be detected by conventional sequencing methods that require reverse transcription.
The commercial launch follows a period in which mRNA has matured from an emergency vaccine platform to a broad therapeutic modality, with personalised cancer vaccines, rare disease treatments, and prophylactic vaccines in development across numerous companies, all of which will require validated, regulatorily accepted QC methodologies before products can enter late-stage trials or commercial supply.
