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Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.
Lonza announced on Jan. 30, 2024 that it has formed a collaboration with Oxford Nanopore Technologies, a provider of nanopore-based molecular sensing technology, to validate—according to current good manufacturing practices (CGMPs)—and commercialize a novel test that accurately determines multiple critical quality attributes (CQAs) of messenger RNA (mRNA) products. According to a company press release, this test is the first-of-its-kind; it directly sequences both the DNA template and the mRNA.
The collaboration aims to address industry and regulatory need for a CGMP-grade common testing method that can simplify and streamline mRNA manufacturing. Under the agreement, Lonza and Oxford Nanopore will focus on adapting the latter’s technology to make it applicable to mRNA production analysis and quality control (QC). The nanopore-based sequencing method makes it possible to use one technology platform to simultaneously measure several quality attributes in mRNA products within the same manufacturing site. Once commercialized, the test aims to substantially shorten analytical testing time and thus reduce the manufacturing timeline for mRNA products.
Through the collaboration, Oxford Nanopore will tech transfer its in-house-developed workflows to Lonza for GMP validation. Oxford Nanopore’s GridION device will be used to generate real-time data and reporting. After validation has been achieved, Lonza intends to include the sequencing technology in its analytical development workflow offering. The company will also support Oxford Nanopore’s efforts to achieve stringent quality requirements for QC compliance. Lonza will pre-validate several CQAs of mRNA products for the novel test at its Geleen, The Netherlands-based analytical development laboratory. Tech transfer will happen at Lonza’s QC laboratories on the same site for CGMP-compliant method validation.
“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,” said Torsten Schmidt, head of mRNA Business Unit, Lonza, in the press release.
“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,” said Gordon Sanghera, CEO, Oxford Nanopore Technologies, in the release.
Source: Oxford Nanopore Technologies