- Oxford Nanopore Technologies and Lonza have launched a direct RNA sequencing-based workflow for GMP quality control testing of mRNA therapeutics.
- The integrated approach combines nanopore sequencing, machine learning-based analysis, and automated software to reduce testing timelines from weeks to less than one day.
Oxford Nanopore Technologies and Lonza have launched a new quality control testing approach for mRNA therapeutics that combines direct RNA sequencing, machine learning-based analytics, and automated software tools to support GMP manufacturing environments.
The companies said the integrated workflow is designed to simplify quality control testing for mRNA products by consolidating multiple analytical readouts into a single platform. According to the announcement, current mRNA testing approaches often rely on multiple analytical systems, single-attribute assays, and extended turnaround times, increasing operational complexity across development and manufacturing.
The new platform uses Oxford Nanopore’s direct RNA sequencing technology to sequence full-length native mRNA molecules without amplification. Combined with machine learning-based data analysis, the workflow can assess multiple critical quality attributes within a single process. The companies stated that the sequence-agnostic platform is intended to support scalability across different mRNA products and manufacturing programs.
“The launch of this direct RNA sequencing technology represents an important step forward in how mRNA quality control can be performed. By combining nanopore sequencing with machine learning based analysis, we are introducing a simplified, multi-attribute approach that better aligns GMP quality control with the pace and complexity of modern mRNA development, while maintaining the rigor required for regulated manufacturing.”
Sönke Stocker, Executive Director of R&D mRNA and External Innovation, Specialized Modalities, Lonza.
Oxford Nanopore and Lonza stated that the integrated workflow has the potential to reduce sample-to-result timelines from weeks to less than one day. The collaboration further expands analytical and manufacturing support capabilities for mRNA therapeutics within the biopharmaceutical outsourcing and CDMO sector.
