Optimizing QC testing of mRNA vaccines and therapeutics

Abstract

Nanopore sequencing emerges as a promising tool for quality control and in-process control in mRNA manufacturing. Its real-time, label-free nature allows for comprehensive monitoring of mRNA synthesis and downstream processing, ensuring full control of the manufacturing process at every stage. Lonza and Oxford Nanopore are collaborating to bring direct mRNA sequencing (including N1-Methyl-pseudouridine) to a regulated environment and establish the new gold standard in sequencing technology. Nanopore sequencing will be used to perform unbiased identity testing while enabling the simultaneous analyses of multiple critical quality attributes such as integrity (mRNA length and poly-A tail length) and capping. The technology has also shown an unmatched potential to be used in complex formulations comprising multiple mRNA molecules. By enabling direct mRNA sequencing, nanopore sequencing streamlines manufacturing workflows, accelerating development timelines and ensuring consistent, high-quality results providing insights into identity, integrity, and composition of mRNA therapeutics at the same time.

Biography

Telmo is the Process and Technology Lead for mRNA at Lonza and ensures that the Lonza platform maintains its leading position in the mRNA space by scouting innovative technologies and processes. He also leads both external and internal projects from research and development to manufacturing. Before joining Lonza, Telmo worked as manager and group lead of the TechRun RNA printer at CureVac. He also has a Master’s in Biological Engineering and a Doctorate degree in Immunology and Infectious diseases.