Continuous Purification for mRNA Vaccine Production: Replacing Chromatography with Adsorptive Membranes

This project focuses on continuous purification of messenger ribonucleic acid (mRNA) vaccine production via adsorptive membranes.

Industry Need

Continuous vaccine production via purification of mRNA can accelerate manufacturing and reduce costs of production.
Current resin-based chromatography for purification of mRNA vaccines is diffusive and slow, with long residence times
Replacing the current method with adsorptive membranes (convective and fast, with short residence times could
Reduce the residence times of the recovery process
Facilitate continuous processing
Retain a higher percentage of folded mRNA due to the reduced treatment tR
Significantly reduce the equipment footprint

Solution

Rensselaer aims to purify labile mRNA quickly at high yield and purity in a continuous production mode to increase quality and reduce production time and cost. The team’s approach is to replace resin-based chromatography with adsorptive membranes.

The project will purify mRNA from a synthetic in vitro transcription (IVT) feed using an affinity membrane process and comparing the performance with commercial affinity chromatography bead column.

The project will also demonstrate the affinity membranes can purify mRNA with similar purity and yield but a faster rate with smaller equipment setup by

Optimizing affinity chemistry for mRNA biding to and elution from pre-selected membranes
Scaling-up from sheet to hollow fiber affinity membranes
Comparing performance (fiber membrane vs affinity chromatography resin vs monolith platform)

Outcomes and Impacts

This project will increase quality, reduce production time and cost by speeding up as well as facilitating continuous production and purification of mRNA vaccines for other virus infections by converting from chromatographic to membrane-based separations.

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Project Lead

Rensselaer Polytechnic Institute