# SBIR Phase I: Hemagglutinin-specific affinity capture membrane for rapid purification of influenza vaccines

> **NIH NIH R43** · PURILOGICS, LLC · 2020 · $251,170

## Abstract

Project Summary
This SBIR Phase I project will develop a novel affinity membrane to address key purification challenges for
producing highly pure and effective recombinant hemagglutinin (rHA) influenza vaccines. In the U.S. each
year, from 5 to 20 percent of the population becomes ill with influenza. Worldwide, there are about 3 to 5
million severe cases and up to 500,000 deaths yearly. Hemagglutinin (HA) is the primary protein in the
influenza vaccines responsible for producing an immune response. Due to its short production time (e.g. one
month) compared to that of cell-based and egg based-vaccines (e.g. three to six months), rHA vaccines show
great promise to rapidly respond to pandemic influenza strains. However, there is a lack of a high-affinity
purification technology for rHAs. Currently, time consuming and multiple low-affinity downstream purification
steps are used to obtain sufficient purity for commercial manufacturing. The goal of this SBIR Phase I project is
to demonstrate the feasibility of developing high-capacity affinity membranes for the rapid, selective purification
of HA. Products derived from this innovation will be first-in-market, disposable membrane chromatography
columns that can simplify and improve the recombinant vaccine purification process by offering increased
affinity, purity, and recovery over conventional methods. The aims of the Phase I study are (1) to demonstrate
the feasibility of synthesizing HA affinity membranes and (2) to test prototype membrane chromatography
columns for capture purification of recombinant HA vaccines and benchmark their performance against existing
technology. In Specific Aim 1, we will evaluate the roles played by synthesis conditions and bind-and-elute
buffer conditions on performance using high-throughput experiments. In Specific Aim 2, Purilogics will
collaborate with researchers at Sciogen, LLC to quantify and benchmark performance for purification of
recombinant HA vaccines prepared by Sciogen from cell supernatant. Multiple iterations of synthesis and
performance characterization will improve membrane performance. In Phase II, Purilogics plans to (i) establish
a scalable process to produce prototypes for comprehensive performance testing, determining sterilization
protocols, product shelf life, and reusability; (ii) conduct field research with industrial partners who are potential
customers; and (iii) test the hypothesis that the receptor-based purification can improve vaccine effectiveness
through animal studies. Market entry for the new column products will be sales to purification scientists and
engineers in biopharmaceutical companies. The estimated total addressable market for prepacked, disposable
HA affinity chromatography columns under development by Purilogics is expected to be > $280M by 2023.

## Key facts

- **NIH application ID:** 10007691
- **Project number:** 1R43AI149987-01A1
- **Recipient organization:** PURILOGICS, LLC
- **Principal Investigator:** Graham Temples
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $251,170
- **Award type:** 1
- **Project period:** 2020-04-01 → 2021-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10007691

## Citation

> US National Institutes of Health, RePORTER application 10007691, SBIR Phase I: Hemagglutinin-specific affinity capture membrane for rapid purification of influenza vaccines (1R43AI149987-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10007691. Licensed CC0.

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