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Evaluation of a rapid multi-attribute combinatorial high-throughput UV-Vis/DLS/SLS analytical platform for rAAV
Xueyuan Liu1,2, Riffard Jean-Gilles3, Julia Baginski1
1Raymond G. Perelman Center for Cellular and Molecular Therapeutics, The Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.
Molecular Therapy. Methods & Clinical Development
|August 22, 2024
Summary
New Stunner technology offers faster, more efficient analysis of recombinant adeno-associated virus (rAAV) gene therapies. This platform accelerates product development by providing accurate capsid and genomic titer, and vector characterization with high throughput.
Area of Science:
- Biotechnology
- Gene Therapy Analytics
- Biopharmaceutical Development
Background:
- Recombinant adeno-associated virus (rAAV)-based gene therapies are crucial, but current analytical methods for product quantification and characterization are inefficient.
- Existing methods are labor-intensive, costly, slow, and have low throughput, hindering product and process development.
Purpose of the Study:
- To evaluate the Stunner platform for quantifying and characterizing rAAVs.
- To compare Stunner's performance against established analytical methods for rAAVs.
- To assess Stunner's suitability for rapid, high-throughput analysis in gene therapy development.
Main Methods:
- Utilized Stunner, a combinatorial analytic technology platform combining UV-Vis absorption with static and dynamic light scattering (SLS/DLS).
- Determined capsid and genomic titer, empty and full capsid ratio, vector size, and polydispersity.
- Tested hundreds of rAAV vectors across various serotypes and transgenes.
Main Results:
- Demonstrated strong correlation between Stunner and established analytical methods.
- Exhibited high reproducibility and repeatability in rAAV analysis.
- Showed applicability of some Stunner analyses to in-process samples from different purification stages.
Conclusions:
- The Stunner platform provides an efficient, cost-effective solution for rAAV analytics.
- Stunner meets the demand for rapid, high-throughput analysis, accelerating gene therapy product and process development.
- The Stunner pipeline streamlines analytics for both small and large batches of rAAV vectors.
