# Development of Custom nanoCLAMP Affinity Chromatography Resins for Fast, Efficient Purification of Plasma Proteins

> **NIH NIH R43** · NECTAGEN, INC. · 2024 · $275,000

## Abstract

The goal of this project is to develop bioprocess-compatible, second generation nanoCLAMP affinity resins to
several high-value plasma-based therapeutics and characterize their performance metrics to provide tools for
improving process efficiency. The plasma-derived therapy market ($19B) is expected to double by 2033, with
new target proteins being rapidly developed. Due to the high cost of the raw material for these therapeutics
there is a critical need for efficient recovery of the proteins in plasma. A bioprocess-compatible affinity
chromatography platform capable of high percentage and specificity recovery of plasma proteins would enable
lower cost production of existing therapeutics and drive development of new ones. The incorporation of affinity
chromatography into downstream processing of non-tagged proteins is hampered by a lack of bioprocess-
compatible affinity ligands with adequate affinity, specificity, and durability. Most available protein-based
affinity ligands are not caustic-stable, limiting their use in repeated cycles of cleaning in place. This work seeks
to apply a novel bioprocess-compatible antibody mimetic platform, called the nanoCLAMP, to affinity
chromatography processing of human plasma to streamline downstream purification of plasma-based
therapeutics. The specific aims of this proposal are to:
 1. Identify panels of nanoCLAMPs to 5 industrially relevant plasma-based therapeutics
 2. Select leads with desired performance metrics.
 3. Purify targets from plasma using lead resins and optimize linker lengths and resin composition to
 maximize % recovery and purity. Scale up production of lead affinity chromatography resins and
 determine performance metrics of final products (10 ml scale) for purification of targets from
plasma.
The successful completion of this project will yield a versatile platform for the development of affinity
chromatography resins utilizing the innovative nanoCLAMP ligand, allowing for the high-purity isolation of
protein components from plasma. The customizable nature of nanoCLAMP ligands will enable tailoring the
resins for specific blood components, addressing current challenges in the purification of complex biological
samples. The outcomes of this research have the potential to revolutionize protein purification processes in
biopharmaceutical and clinical applications, enhancing the efficiency and reliability of downstream processing.

## Key facts

- **NIH application ID:** 11006459
- **Project number:** 1R43TR005370-01
- **Recipient organization:** NECTAGEN, INC.
- **Principal Investigator:** Richard John Suderman
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $275,000
- **Award type:** 1
- **Project period:** 2024-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11006459

## Citation

> US National Institutes of Health, RePORTER application 11006459, Development of Custom nanoCLAMP Affinity Chromatography Resins for Fast, Efficient Purification of Plasma Proteins (1R43TR005370-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11006459. Licensed CC0.

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