Improving the Accessibility of AAV Quantification in Gene Therapy Development
Accurate capsid quantification remains one of the persistent bottlenecks in AAV development.
Adeno-associated virus (AAV) is widely used in gene therapy as a vector to deliver genetic material into patient cells due to its specificity and low immunogenicity. Accurate AAV quantification and profiling of the proportions of empty, partially filled, overfilled and full AAV capsids is essential for the development of safe and effective gene therapies. Capsid heterogeneity can contribute to variability across production batches, potentially amplifying immune activation and compromising transduction efficiency.
Managing the removal of product impurities whilst simultaneously preserving the yield of full capsids in AAV development can be extremely challenging and requires analytical platforms that are highly sensitive, cost-effective and scalable.
Technology Networks spoke with Dr. Ruizhi Wang, founder and CEO of Abselion, to learn more about how the company's benchtop platform Amperia™ is designed to overcome bottlenecks in accurate capsid quantification. Wang also discusses the importance of robust analytics in the field and what needs to be done to move towards standardization in gene therapy development.
From your perspective, what are the key limitations gene therapy developers face with existing AAV quantification methods, and how does the Amperia benchtop platform address these challenges?
Ruizhi Wang, PhD (RW):
Accurate capsid quantification remains one of the persistent bottlenecks in AAV development. Enzyme-linked immunosorbent assay (ELISA) assays are widely used and provide valuable data, but they can be variable and time-consuming. Digital droplet PCR (ddPCR) is highly sensitive for genome copy measurements, yet it does not directly quantify capsids and is less suited for routine monitoring. Other analytical methods, such as high-performance liquid chromatography (HPLC) or mass spectrometry, generate important insights but rely on specialist infrastructure and expertise, making them harder to apply day to day. The result is that many teams still struggle to obtain timely, consistent data at the points in development when they need it most.
Amperia was developed to fill this gap. The benchtop platform uses sensor strips in a simple dip-read format, powered by our Redox Electrochemical Detection technology and ready-to-use assay kits. It sits in the sweet spot where accuracy, speed and cost-effectiveness meet. The workflow is straightforward, the throughput matches the needs of most development teams and the data are robust and consistent to guide decisions with confidence. In practice, this makes capsid measurements more routine and accessible, turning what has long been a bottleneck into a manageable part of everyday development.
BF:
RW:
A major advantage of using CaptureSelect reagents in our kits is the confidence they give users in terms of specificity and consistency. These ligands are engineered single-domain antibodies, designed to recognize their targets with high selectivity and with minimal lot-to-lot variation. By integrating them into our Amperia kits, we bring that reliability into a straightforward benchtop format.
For AAV quantification, this translates directly into practicality. The AAVX reagent provides broad coverage across many serotypes in a single assay, so researchers don’t need to validate multiple capture antibodies before generating data. AAV9, however, has unique capsid properties, and the dedicated CaptureSelect reagent ensures this important vector can be measured accurately and reliably.
On Amperia, these trusted affinity reagents are combined with our electrochemical dip-sensor readout to deliver robust, quantitative data in a simple workflow. The result is improved assay consistency, easier adoption across projects and greater confidence in the measurements that support process and analytical development in the gene therapy field.
BF:
RW:
As mentioned earlier, existing quantification methods each have their own strengths but often come with trade-offs in time, complexity or accessibility. Compared with these traditional assays, Amperia offers a much simpler and faster way to obtain reliable capsid data.
The kits can be applied directly to crude samples, reducing the need for extensive purification, while the touch-screen interface guides users through setup and streamlines the process. Integrated analysis and data visualization provide results quickly and clearly, without the need for additional software or specialist expertise. Combined with the specificity of CaptureSelect reagents and the reproducibility of the electrochemical readout, this makes capsid quantification faster, easier and more consistent in a compact benchtop format.
BF:
RW:
The gene therapy field is at a point where success depends not only on developing new vectors, but also on ensuring that measurements are reliable and comparable across labs and stages of development. Standardization and robust analytics are becoming central to this progress.
Technologies like Amperia can help by turning capsid quantification into a more routine, dependable measurement. With defined reagents, a guided workflow and integrated analysis, it provides a consistent framework that different teams can adopt, reducing the variability that has often slowed development.
Looking ahead, I see the biggest need in bringing different analytical approaches closer together – aligning outputs from methods like ELISA, ddPCR, HPLC and emerging platforms, and building stronger reference standards. No single tool can solve all these challenges, but Amperia can form part of the foundation by offering data that are both practical and reproducible, supporting the broader move toward standardization in gene therapy.
BF:
RW:
Amperia already extends beyond AAV, with Protein A and Protein G kits for antibody quantification, and an established His-tag detection assay. These applications highlight how the platform can be adapted to different biomolecules that are central to biologics and gene therapy development, from cell line screening to vector production.
Looking ahead, we see strong potential to expand further. The underlying sensor and electrochemical technology are adaptable, which opens the door to developing assays for other viral vectors, additional affinity tags and proteins of interest in cell and gene therapy processes. We are also exploring opportunities in process monitoring and product characterization, where rapid, routine measurements could accelerate development timelines and reduce costs.
The broader vision is for Amperia to evolve into a multipurpose analytical toolkit on the benchtop: a single, easy-to-use platform that provides researchers and industry teams with consistent, high-quality data across programs. By making essential analytics more practical and accessible, we aim to enable smoother development of the next generation of therapies.
