Inline Monitoring in mRNA Downstream Processing
Taking a step towards continuous
mRNA manufacturing
Real-time monitoring of mRNA concentrations is essential for data collection in drug production, serving as evidence that manufacturer adhered to certain product characteristics. Monipa addresses this need by providing fast and reliable measurements of mRNA concentration at critical stages of the UF/DF process. Adopting Monipa can significantly reduce analysis timelines from weeks to as little as a day and helps understand potential impacts of changing process parameters.
Benefits
Speeds up regulatory compliance with continuous data collection
Reduces time and costs by replacing traditional methods with inline monitoring
Real-time detection of process deviations in critical steps like IVT, purification, and LNP formulation
Enhances decision-making through data-driven process optimization.
mRNA Manufacturing Process Overview
Monipa can be integrated directly inline with a tangential flow filtration (TFF) system, where it monitors plasmid DNA (pDNA) concentration during the ultrafiltration phase. As the process flows, Monipa provides continuous data, enabling real-time adjustments to ensure optimal concentrations are achieved. During the diafiltration step, Monipa tracks buffer exchange throughout, giving instant feedback on progress and allowing for timely decision-making. This integration eliminates the need for offline sampling and facilitates the process.