# SBIR Phase II: High-capacity membrane for fast and selective capture of mRNA

> **NIH NIH R44** · PURILOGICS, LLC · 2021 · $977,854

## Abstract

Project Summary
This SBIR Direct to Phase II project will develop the first affinity membrane for purifying mRNA with high
capacity, selectivity, and throughput. mRNA medicines have the potential to address a wide variety of
pathologies. FDA emergency use authorizations for two mRNA-based COVID-19 vaccines represent the
dawning of a new era of mRNA therapies. However, a company pioneering mRNA medicines has revealed that
the lack of high throughput purification processes is a major hurdle that must be addressed in the upscaling of
industrial mRNA. Purilogics expects that commercialization of the proposed innovation will have a major impact
on the development of mRNA medicines by providing high-throughput solutions to the purification challenges
experienced at the discovery and industrial production scales. By reducing purification cycles from hours to
minutes, the innovation will increase productivity and, by association, improve patient accessibility to mRNA
vaccines and medicines. The products of this project will be first-in-market, prepacked affinity membrane multi-
well plates and chromatography columns and cassettes that can rapidly isolate and purify mRNA drugs from in
vitro transcription mixture. Competing products have low productivity because of the long residence times
needed for purification. In addition, their capacities are extremely low for large size mRNA. In our initial study,
we proved the feasibility of fabricating high productivity mRNA affinity membranes. Membrane chromatography
column prototypes dramatically outperformed competing commercial products, and the productivity and
reusability milestones exceeded the defined acceptance criteria for moving to Phase II. Our industry
collaborator evaluated the prototypes using proprietary mRNA feed streams. The purifications were faster and
attained higher mRNA recovery and similar purity compared to competing products. The Phase II aims are (i)
to develop mRNA affinity membranes with increased capacity that enable reduced purification times for mRNA
of all sizes; (ii) to finalize a scalable process for mRNA affinity membranes and develop prototypes, and (iii) to
determine mRNA affinity membrane column operating ranges and conduct field research on prototypes
through industry collaboration. In Specific Aim 1, we will systematically evaluate the roles played by synthesis
conditions and membrane pore size on performance. In Specific Aim 2, we will establish a process to produce
the membranes. We will fabricate a series of membrane columns, laterally fed cassettes, and multi-well
membrane plate prototypes. In Specific Aim 3, Purilogics will collaborate with an industry leader to evaluate
prototypes for capture step purification of mRNA at multiple scales (research/pilot/production). Market entry for
new bioprocessing tools is prior to clinical phase II trials. With the majority of mRNA drugs in phase I and II
clinical trials, the time to develop a high-productivity mRNA purification tec...

## Key facts

- **NIH application ID:** 10325330
- **Project number:** 1R44GM144060-01
- **Recipient organization:** PURILOGICS, LLC
- **Principal Investigator:** Graham Temples
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $977,854
- **Award type:** 1
- **Project period:** 2021-08-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325330

## Citation

> US National Institutes of Health, RePORTER application 10325330, SBIR Phase II: High-capacity membrane for fast and selective capture of mRNA (1R44GM144060-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10325330. Licensed CC0.

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