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Principal Investigator: Graham Temples
Organization: PURILOGICS, LLC
Fiscal Year: 2021
Award: $977,854
Funding agency: National Institute of General Medical Sciences
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 technology is now. The addressable
market for prepacked mRNA capture-step chromatography products is expected to reach $200 million by 2026.
Terms: <2'-Deoxythymidine><2019-nCoV vaccine><Address><Advanced Development><Affinity><Binding><Binding Sites><Biological><Buffers><COVID-19><COVID-19 vaccine><COVID19><COVID19 vaccine><CV-19><CV19><Cancers><Characteristics><Chromatography><Column Chromatography><Combining Site><Communicable Diseases><Consumption><Contracting Opportunities><Contracts><DThyd><Deoxythymidine><Development><Drug Design><Drugs><Early-Stage Clinical Trials><Engineering><FDA EUA><FDA Emergency Use Authorization><Feasibility Studies><Feeds><Food and Drug Administration EUA><Food and Drug Administration Emergency Use Authorization><Gene Transcription><Genetic Transcription><Goals><Hour><In Vitro><Industrialization><Industry><Industry Collaboration><Industry Collaborators><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Length><Ligands><Malignant Neoplasms><Malignant Tumor><Manufacturer><Manufacturer Name><Medication><Medicine><Membrane><Messenger RNA><Molecular Interaction><Oligo><Oligonucleotides><Pathology><Patients><Performance><Pharmaceutic Preparations><Pharmaceutical Agent><Pharmaceutical Preparations><Pharmaceuticals><Pharmacologic Substance><Pharmacological Substance><Phase><Phase 1 Clinical Trials><Phase 2 Clinical Trials><Phase I Clinical Trials><Phase II Clinical Trials><Plant Resins><Play><Poly(A)+ mRNA><Polyadenylated mRNA><Process><Production><Productivity><Protein Replacement Therapy><Public Health><RNA Expression><RNA vaccine><RNA-based vaccine><Reactive Site><Recovery><Reporting><Research><Role><SARS-CoV-2 vaccine><SARS-CoV2 vaccine><SARS-coronavirus-2 vaccine><SBIR><Scientist><Series><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe acute respiratory syndrome coronavirus 2 vaccine><Small Business Innovation Research><Small Business Innovation Research Grant><Speed><Stream><Syringes><TdR><Technology><Testing><Therapeutic><Thymidine Deoxyriboside><Time><TimeLine><Transcription><Translating><Vaccines><Work><base><bioprocess><commercialization><corona virus disease 2019><corona virus disease 2019 vaccine><coronavirus disease 2019><coronavirus disease 2019 vaccine><density><design><designing><developmental><drug development><drug/agent><emergency use authorization><enzyme replacement therapy><experience><improved><innovate><innovation><innovative><mRNA><mRNA vaccine><mRNA-based vaccine><malignancy><meetings><membrane structure><milligram><neoplasm/cancer><oligo (dT)><oligodeoxythymidylic acid><oligos><operation><performance tests><phase I protocol><phase II protocol><plasmid DNA><polyadenylated messenger RNA><prototype><public health relevance><residence><residential building><residential site><resin><social role><success><therapeutic agent development><therapeutic development><tool><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine for novel coronavirus><vaccine safety>