AAV Capture Purification Scaling Case Study

This technical report presents a case study on the scalability and reproducibility of the AAV capture purification step using the KRM™10 Chromatography System. The study was conducted in collaboration with Forge Biologics and aimed to evaluate the performance of the KRM™10 system in AAV manufacturing, focusing on its ability to scale from benchtop to clinical manufacturing. The KRM™10 system was tested for its process yield, product purity, and overall robustness. The report details the design features of the KRM™ platform, including minimal hold-up volume and advanced pump control, which contribute to enhanced process performance. The case study outlines the methodology used in scaling the AAV capture purification process, including the use of a 500-L bioreactor and the steps involved in downstream processing. Analytical results are provided to demonstrate the effectiveness of the KRM™10 system in maintaining quality attributes during scale-up. The findings indicate successful alignment of chromatograms and consistent recovery rates across different scales, confirming the system's suitability for high productivity in viral vector manufacturing.