Strategies for Process Intensification and Purity
A data-driven approach to downstream process development is tailored to the specific AAV serotype and intended clinical application. While platform methodologies provide a valuable starting point for common capsids (e.g., AAV8, AAV9), novel or engineered capsids often require customized development to optimize separation and yield.
Our scientific team designs purification trains that balance speed with product quality, a capability a partner recognized as a “Vast knowledge in all aspects of vector production and analytics.” This involves a multi-step chromatography process, typically combining affinity chromatography with ion-exchange and size-exclusion methods, complemented by tangential flow filtration (TFF) for concentration and buffer exchange.
The translational impact of a highly pure and potent vector preparation is significant. Demonstrating high activity of the therapeutic payload, as shown in studies with rAAV-delivered therapeutics, is foundational to building a data package that supports the intended biological effect for IND submissions to the FDA (PMID: 36006993).
This focused work on downstream processing ensures that the vectors produced in our large-scale systems are ready for pivotal preclinical evaluation. For a comprehensive overview of how capsid engineering and scalability fit into a successful AAV program, our webinar on initiating vector programs provides further context on preclinical safety profiling.
Learn more about our comprehensive services at the parent hub: Large-Scale AAV Manufacturing and Process Development.
