🧬 For AAV-based products, regulatory agencies require demonstration of product potency, but challenges persist due to variability in both in vivo and in vitro cell based assays and lack of direct readout for non-enzymatic proteins.
⚙️ Thanks to our exclusive MyoScreen™ platform, CYTOO delivers robust, GMP-compatible assays that quantify both expression and functional activity of structural proteins.
One impressive example is our Duchenne Muscular Dystrophy (DMD) potency assay, which meets FDA requirements for demonstrating functional potency and combines quantitative imaging and custom analysis to capture disease-relevant protein colocalization with high precision and reproducibility.
📊 Unlike bulk biochemical tests, our quantitative imaging offers spatial, single-cell insights with superior sensitivity and throughput. MyoScreen™ supports GMP potency assays essential for lot release of complex gene therapies targeting skeletal and cardiac muscle.
🤝 Partner with CYTOO through our flexible R&D model to accelerate your development and ensure regulatory success! Contact us.
