Oxford Nanopore partners with Lonza to accelerate analysis of mRNA products
Oxford Nanopore Technologies is set to collaborate with pharmaceutical partner firm Lonza on a novel test to help speed up the analysis of mRNA products.
mRNA is an emerging class of biotherapeutics which could be used to prevent and treat various infectious diseases, cancers, autoimmune and genetic disorders.
These products, like the Covid-19 vaccines, can be designed, manufactured and brought to market relatively quickly – but currently require a lot of time and resources for analytical testing.
The collaboration will therefore focus on adapting Oxford Nanopore’s technology, which directly sequences the native RNA molecule, to apply it to mRNA production analysis and quality control.
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This will allow several quality attributes to be measured at the same time, on the same site, using a single technology platform, granting manufacturers a significant competitive advantage.
The aim is to bring the test in line with current Good Manufacturing Practice (cGMP), an industry standard.
Gordon Sanghera, CEO of Oxford Nanopore, said: “mRNA technologies have already delivered a profound impact in recent years, and the industry is growing into many novel areas, including personalised cancer vaccines.
“With Lonza, we’re excited to develop an enabling technology by developing the first GMP-grade test to analyse 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.”
The collaboration will see Oxford Nanopore share its inhouse tech transfer workflows with Lonza, using its GridION device to generate real-time data during testing.
Once validated, Lonza plans to use the sequencing technology in its analytical development workflow, testing the technology at its lab in Geleen, Netherlands.
Torsten Schmidt, head of Lonza’s mRNA business unit, added: “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.”
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