# SBIR Phase II: Protein A Membrane Columns for Rapid Protein Purification

> **NIH NIH R44** · PURILOGICS, LLC · 2020 · $681,616

## Abstract

Project Summary
This SBIR Phase II project will address the need for capture-step chromatography products that dramatically
increase the isolation and purification speed for therapeutic biologics, particularly monoclonal antibody drugs.
Numerous campaigns are under way to develop new biologics for treating chronic conditions, and there is
increasing demand for affordable and fast, small-batch production runs. Technologies like the one proposed
will contribute to improving human health by enabling the rapid production of affordable medications. The
products of this SBIR Phase II project will be prepacked, disposable Protein A membrane chromatography
columns that rapidly isolate and purify monoclonal antibody drugs from cell culture supernatant. Available
products have low productivity because of the long column residence times needed for purification. Based on
customer discovery interviews with over 180 biopharmaceutical experts, Purilogics expects that the products of
this Phase II project will have a major impact on the industry by reducing the purification cycle from hours to
minutes. In Phase I, we proved the feasibility of fabricating high productivity Protein A membrane columns.
Product prototypes significantly outperformed the best competing commercial products, and the productivity
performance metric exceeded the defined acceptance criterion for moving to Phase II. University collaborators
compared the prototypes to a commercial resin for purification of an anti-HIV human monoclonal antibody. The
purification was faster and attained the same antibody recovery and purity. The aims of the Phase II study are
(i) to develop Protein A membranes with increased capacity and reduced purification time; (ii) to finalize a
production process for Protein A membrane columns with defined product shelf life and reusability, and (iii) to
determine Protein A membrane column operating ranges and conduct field research on prototypes through
university and industry collaborations. 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 prototypes for determining sterilization protocols, product shelf life, and reusability over 100 cycles.
We will fabricate a spiral-wound membrane column prototype to collect data for predicting performance at large
scale. In Specific Aim 3, Purilogics will collaborate with researchers at Clemson University to delineate the
Protein A column operating conditions. Field research will be done at the facilities of three industry partners to
study purification schemes for 8-10 different monoclonal antibodies and compare performance against
commercial products. Initially, market entry for the new column products will be sales to purification scientists
and engineers in biopharmaceutical companies. These individuals are end-users, influencers and decision
makers. The addressable market for prepacked, dis...

## Key facts

- **NIH application ID:** 9878895
- **Project number:** 5R44GM125429-03
- **Recipient organization:** PURILOGICS, LLC
- **Principal Investigator:** Jinxiang Zhou
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $681,616
- **Award type:** 5
- **Project period:** 2017-08-01 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9878895

## Citation

> US National Institutes of Health, RePORTER application 9878895, SBIR Phase II: Protein A Membrane Columns for Rapid Protein Purification (5R44GM125429-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9878895. Licensed CC0.

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