P073
Optimizing analytical methods for product characterization during rAAV manufacturing process
A Manterola(1) N Insausti(1) A Carreras(1) A Alzualde(1) H Iribar(1) C Trigueros(1)
1:Viralgen Vector Core
Viralgen is a CDMO specialized in the production of rAAV viral vectors. Our streamlined facilities maximize the performance and efficiency of our proprietary Pro10™ suspension manufacturing platform. We are focused on the continuous improvement of our production processes, as well as Quality Control (QC) analytics to ensure the best product quality. In this context, accurate titration of vectors and optimal detection of process-associated impurities are critical aspects to achieve this objective.
Automated nanoliter-scale immunoassays (Gyrolab® platform in combination with the ready-to-use Gyrolab® AAVx titer kit) has allowed us to improve the quality of our analytical results. Obtaining accurate and comparable titration data in less time and significantly reducing the volume of reagents and samples required for each test has resulted in a considerable increase in the productivity within a standardized process.
In addition, replacing the traditional ELISA currently used for HCP detection in HEK293 by the ready-to-use kit from Gyrolab® has helped us to improve the efficiency of the assay. By using this procedure, we have been able to increase the reproducibility and detection sensitivity of the assay, ensuring the minimum concentration of Host Cell Proteins in our Products.
