Late-Stage Process Characterization for rAAV Manufacturing

This technical report outlines the late-stage process characterization for recombinant adeno-associated virus (rAAV) manufacturing at Forge Biologics. It details the integrated framework that connects critical quality attribute assessment, parameter risk ranking, scale-down model qualification, and failure mode analysis into a continuous workflow. The report emphasizes the importance of establishing robust manufacturing processes that are compliant with regulatory requirements, particularly during the transition from early to late-stage development. It describes the lifecycle of late-stage process development, comparing it to early-stage efforts, and highlights the significance of extensive process characterization, including design of experiments (DoE) and risk assessments. The document also presents a case study on the use of affinity chromatography for the purification of AAV, demonstrating the effectiveness of miniaturized RoboColumn formats as predictive models for larger-scale processes. The findings support the need for a well-characterized manufacturing process to ensure successful regulatory submissions and commercial readiness.