Oxford Nanopore, Lonza to collaborate on QC test for mRNA therapeutics

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Oxford Nanopore announced that it will collaborate with biotech manufacturer Lonza on commercializing a current good manufacturing practices  (cGMP)-validated test to enable advanced analysis for quality attributes of messenger RNA (mRNA) products through directly sequencing both the DNA template and the mRNA.

Financial details of the deal were not disclosed.

While mRNA biotherapeutics can be designed and developed quickly, the necessary analytical testing can take significant time and resources. The purpose of the collaboration is to develop a cGMP-grade common testing method that will simplify and streamline this process, the Basel, Switzerland-based Lonza said in a statement.

The firm noted that Oxford Nanopore’s technology is the first and only approach that can directly sequence the native RNA molecule. The nanopore-based sequencing method allows several quality attributes in mRNA products to be measured simultaneously using one platform. The collaboration between Lonza and Oxford Nanopore will focus on adapting this technology to apply to mRNA production analysis and quality control (QC).

Oxford Nanopore will develop the test in-house using its GridIon sequencing platform and transfer the workflows to Lonza. Following successful cGMP validation of the test, Lonza will include the sequencing technology in its analytical development workflow while supporting Oxford Nanopore in achieving quality requirements for QC compliance.

Lonza will prevalidate several critical quality attributes of mRNA products for the test at its analytical development laboratory in Geleen, the Netherlands, and will validate the method at onsite QC laboratories there.

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