# A high-efficiency, low-cost, single-use purification technology for therapeutic antibody manufacturing

> **NIH NIH R44** · BONDWELL TECHNOLOGIES LP · 2024 · $1,253,658

## Abstract

Therapeutic antibodies have had a profound impact on treatment of many types of cancer and
autoimmune diseases with many new therapeutics in development. However, antibodies are
extremely expensive to produce, and large amounts of antibody are required to achieve clinical
efficacy. In our 268 interviews with industry experts and extensive research of the literature,
Protein A-based purification is the largest pain point in mAb manufacturing. The global Protein A
resin market size was estimated at $1.36 B in 2022 and is expected to expand at a CAGR of
11.4%. This market can be divided into the classical resins that have dominated the market and
new alternatives which include membranes. There is a strong desire to move away from resins;
however, a lack of alternatives with superior performance have prevented this. Our Phase I and
II data demonstrate that we have considerable advantages over incumbent suppliers by providing
a high binding capacity, high-flow, single-use membrane that doesn’t rely on crosslinking. At the
end of Phase IIB, we will produce our minimally viable product: a low-cost, high-capacity, single-
use antibody purification membrane that has been validated by key industry players and ready to
be displayed internationally. To do this we will accomplish the following Aims: 1) Industrial Scale
Production runs of protein monomers 2) Produce significant quantities of Bondwell Material 3)
Incorporate BT materials into our custom membrane 4) Validate our 2nd generation membranes
with industry partners. The slow adoption rate of new technologies, preference for brand
reputation, compliance with FDA SOPs, global supply risk, and long runway to revenue lead to
start-ups similar to ours being acquired before any sales occur. Therefore, our goal is not to
manufacture and sell this product but to pursue an early exit through licensing, partnership with,
or acquisition by, established companies. To accomplish this, we will leverage the data generated
from industry partners during this Phase IIB proposal to generate high profile scientific
publications and presentations at leading conferences.

## Key facts

- **NIH application ID:** 10822865
- **Project number:** 2R44GM134776-04
- **Recipient organization:** BONDWELL TECHNOLOGIES LP
- **Principal Investigator:** David W. Howell
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,253,658
- **Award type:** 2
- **Project period:** 2019-09-01 → 2026-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10822865

## Citation

> US National Institutes of Health, RePORTER application 10822865, A high-efficiency, low-cost, single-use purification technology for therapeutic antibody manufacturing (2R44GM134776-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10822865. Licensed CC0.

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