Lonza has collaborated with Oxford Nanopore to address the need for a common testing method to manufacture messenger RNA (mRNA).
According to the terms of the agreement, Oxford Nanopore will use its nanopore sequencing and the GridION device to directly sequence the native RNA molecule. The data will be validated by the contract development and manufacturing organization (CDMO) Lonza.
Lonza aims to pre-validate several critical quality attributes of mRNA products for the novel test at its analytical development laboratory in Geleen, Netherlands, and technology transfer to QC laboratories on the same site for cGMP-compliant method validation.
“Our shared objective is to simplify quality control and release processes to bring mRNA therapies to market quicker,” a spokesperson for Lonza told BioProcess Insider.
“Through the collaboration, we aim to validate and commercialize a […] novel test to accurately determine multiple critical quality attributes of mRNA products by directly sequencing both the DNA template and the mRNA.”
The Swiss CDMO aims to include the sequencing technology in its analytical development workflow offering, and support Oxford Nanopore in achieving stringent quality requirements for QC compliance.
“It has been a challenge for this market […] to directly sequence the native RNA molecule, so with nanopore sequencing and the accessibility of the GridION this is now possible,” a spokesperson for Oxford Nanopore told us.
“The nanopore-based sequencing method will allow several quality attributes in mRNA products to be measured simultaneously, on the same manufacturing site, using one technology platform.”
According to the firm, Oxford Nanopore has developed an electronics-based sequencing technology that offers scalability with real-time data delivery and the ability to elucidate accurate, rich biological data through the analysis of short to ultra-long fragments of native DNA or RNA.
The GridION is a self-contained, easily deployable benchtop device designed to run and analyze up to five MinION Flow Cells. According to the firm, it can generate up to 250 Gb of data for real time analysis. The technology does not require regulatory approval, but the partnership will work towards cGMP validation.
The financials associated with this collaboration have not been disclosed.
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