To improve mRNA product analysis, the Lonza Group Ltd. and Oxford Nanopore Technologies plc. are working together to develop and market a test to assess multiple critical quality attributes of mRNA products
The significance of mRNA technology has been highlighted in recent years, particularly with its role in rapidly developing and bringing COVID-19 vaccines to market. However, the analytical testing of mRNA products, including indirect mRNA sequencing, is time-consuming and resource-intensive. Swiss contract drug manufacturer Lonza Group Ltd. has entered a collaboration with Oxford Nanopore Technologies plc. to enhance the analysis of mRNA products, a vital class of biotherapeutics instrumental in the prevention and treatment of various diseases including infectious diseases, cancers, and genetic disorders. This partnership focuses on the cGMP validation and commercialisation of a novel test, that aims to accurately assess multiple critical quality attributes of mRNA products by directly sequencing both the DNA template and the messenger RNA (mRNA) itself.
Oxford Nanopore’s technology, which can directly sequence the native RNA molecule, will be adapted for use in the analysis and quality control of mRNA production. The nanopore-based sequencing method allows for the simultaneous measurement of several quality attributes in mRNA products on the same manufacturing site using a single technology platform. This approach is expected to reduce analytical testing time, offering a competitive advantage in the manufacturing of mRNA products. Torsten Schmidt, head of the mRNA business unit at Lonza, emphasised the rapid expansion of the mRNA market and the reliance on traditional analytical technologies. “Faster and more effective mRNA analytics could simplify the regulatory review process and accelerate the development path,” he noted.
As part of the collaboration, Oxford Nanopore will transfer workflows developed in-house to Lonza for GMP validation. Following this validation, Lonza intends to incorporate the sequencing technology into its analytical development workflow offerings, furthering the impact of this innovative partnership in the field of mRNA technology. This technology could be crucial not only for pandemic preparedness but also for ongoing research and development in mRNA therapeutics.