- Collaboration aims to commercialize a Current Good Manufacturing Practice (cGMP) validated test to enable advanced and innovative analysis for multiple critical quality attributes of mRNA products
- The simplification of analytical testing requirements could accelerate the path to market for mRNA products such as vaccines for infectious diseases
Basel, Switzerland and Oxford, UK, 30 January 2024 – Lonza, a global development and manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, today announced a collaboration with Oxford Nanopore Technologies plc (Oxford Nanopore), a company delivering a new generation of nanopore-based molecular sensing technology. The collaboration aims to cGMP validate and commercialize a first-of-its-kind novel test to accurately determine multiple critical quality attributes of mRNA products by directly sequencing both the DNA template and the messenger RNA (mRNA).
mRNA is an emerging class of biotherapeutics, offering new and unique opportunities for prevention and treatment of various infectious diseases, cancers, autoimmune and genetic disorders.
mRNA products can be designed, manufactured, and brought to market in very short timelines, as demonstrated by the production of COVID-19 vaccines. However, a significant amount of time and resources are required for analytical testing, including indirect mRNA sequencing. The collaboration aims to address this pressing industry and regulatory need for a cGMP-grade common testing method to simplify and streamline mRNA manufacturing.
Oxford Nanopore’s technology is the first and only approach that can directly sequence the native RNA molecule. The collaboration between Lonza and Oxford Nanopore will focus on adapting this technology to apply to mRNA production analysis and quality control (QC).
The nanopore-based sequencing method allows several quality attributes in mRNA products to be measured simultaneously, on the same manufacturing site, using one technology platform. Once commercialized, the nanopore-based test aims to substantially reduce analytical testing time, which can deliver significant competitive advantage for the manufacture of mRNA products.
As part of the collaboration, Oxford Nanopore will tech transfer workflows developed in house to Lonza for GMP validation, using its GridION™ device to generate real-time data and reporting. Following successful validation, Lonza intends to include the sequencing technology in its analytical development workflow offering, and support Oxford Nanopore in achieving stringent quality requirements for QC compliance. Lonza will pre-validate several critical quality attributes of mRNA products for the novel test at its analytical development laboratory in Geleen (NL) and technology transfer to QC laboratories on the same site for cGMP-compliant method validation.
Torsten Schmidt, Head of mRNA Business Unit, Lonza, commented: “While the mRNA market is fast-expanding, as a relatively new modality it still relies on the use of traditional analytical technologies. Faster and more effective mRNA analytics could simplify the regulatory review process and accelerate the development path. This collaboration underlines the commitment of Lonza and Oxford Nanopore to bring innovation to the market. Our shared objective is to simplify testing processes to bring mRNA therapies to market quicker.”
Gordon Sanghera, Chief Executive Officer, Oxford Nanopore Technologies, added: “mRNA technologies have already delivered a profound impact in recent years, and the industry is growing into many novel areas, including personalized cancer vaccines. With Lonza, we are excited to develop an enabling technology by developing the first GMP-grade test to analyze multiple critical quality attributes of mRNA products. Nanopore sequencing offers a transformational new approach with its one-of-a-kind ability to sequence native RNA to deliver robust and accurate testing of multiple critical quality attributes, in situ and with rapid turnaround times. Not only may this help with pandemic preparedness, but it could also be crucial in ongoing R&D advancements for mRNA therapeutics.”