Lonza and Oxford Nanopore to Collaborate on mRNA Analysis

30.01.2024 - Swiss contract development and manufacturing organization (CDMO) Lonza will collaborate with Oxford Nanopore Technologies, a UK-based 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).

Messenger RNA is an emerging class of biotherapeutics, offering new and unique opportunities for prevention and treatment of various infectious diseases, cancers, autoimmune and genetic disorders.

Products based on mRNA can be designed, manufactured, and brought to market in very short timelines, as demonstrated by the production of Covid-19 vaccines. However, Lonza said, 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 said to be the first and only approach that can directly sequence the native RNA molecule. The collaboration between the two companies will focus on adapting this technology to apply to mRNA production analysis and quality control (QC).

According to Lonza, 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 could substantially reduce analytical testing time.

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, the Netherlands, and technology transfer to QC laboratories on the same site for cGMP-compliant method validation.

Torsten Schmidt, head of Lonza’s mRNA business, 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.”

“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,” added Gordon Sanghera, CEO of Oxford Nanopore.