Two For One: A Single QC Assay To Quantify Two Plasmid Impurities (Cap/kanR) Across A Number Of Serotypes Reduces Time & Costs For rAAV Batch Release

By S. Beer, R. Kober, F. Thoennissen, M. Magerl, K. Breunig, F. Dunker-Seidler, R. Feiner, S. Geiger, and S. Schermann

This poster introduces an innovative approach to quality control (QC) assays in recombinant Adeno-Associated Virus (rAAV) production by demonstrating a single assay capable of simultaneously quantifying two key plasmid impurities: cap and kanamycin resistance (kanR) genes. Monitoring plasmid impurities is a critical aspect of batch release, ensuring compliance with regulatory standards and maintaining therapeutic product integrity.

The study showcases how this dual-function assay performs across multiple AAV serotypes, providing a robust and versatile solution for QC workflows. The streamlined process significantly reduces assay time and associated costs without compromising sensitivity or accuracy. Additionally, the assay’s compatibility with diverse serotypes underscores its potential to standardize impurity quantification across different rAAV production pipelines.

By minimizing resource demands while delivering precise and reliable results, this methodology represents a breakthrough in QC efficiency for rAAV batch release. Download the poster to explore the assay design, validation data, and potential applications in greater detail.