# Nanopore Methods for Determining Capsid Viability

> **NIH FDA R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2022 · $461,132

## Abstract

Nanopore Methods for Determining Capsid Viability
ABSTRACT
AAV (adeno-associated virus) vectors are quickly becoming an important therapeutic tool for
treatment of a variety of diseases, resulting in a significant increase in the number of
applications to the FDA for approvals for treatment of various diseases. Precise
characterization of these AAVs is extremely important for process control and determination of
the effectiveness of the final product for both production efficiency and regulatory/quality
reasons. We have developed nano-fluidic, synthetic pore-based sensors capable of detecting
and quantifying various nanoparticles. These existing sensors can be modified for application to
capsid characterization. Demonstrated applications of this technology include DNA and RNA
sequencing, SARS-CoV-2 virus detection from saliva (including viral load and infectivity
classification) using resistive pulse sensing (RPS), and analysis of ligase detection reaction
(LDR) products utilizing Time-of-Flight (TOF) capabilities. Specifically for this project, we will
use the nanopore technology to detect capsids and characterize them as either full or empty
(Aim 1) and we will extend the sensor capabilities to address high-throughput strategies for
inline analysis (Aim 2). Finally, we will implement the sensors into AAV production, validate
their responses against established QCAs and use sensor data to optimize production
processes (Aim 3). We expect these developments to result in sensor systems that will help to
improve AAV production efficiencies, improve final product infectivity, and provide important
quality assurance data.

## Key facts

- **NIH application ID:** 10486102
- **Project number:** 5R01FD007476-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Kimberly Ritola
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $461,132
- **Award type:** 5
- **Project period:** 2021-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10486102

## Citation

> US National Institutes of Health, RePORTER application 10486102, Nanopore Methods for Determining Capsid Viability (5R01FD007476-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10486102. Licensed CC0.

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