AAVeritas – Development of AAV Bioprocessing and Purification Supported by Automatized Analytics

Challenge

Viral therapeutics are versatile and require tailored production and purification methods. For example, adeno-associated viruses (AAV) are used as vectors for numerous therapies. Given the growing demand, the development of efficient manufacturing strategies becomes increasingly important.

Objectives and project plan

This project focuses on establishing automated AAV analytics as a tool for accelerating the development of upstream (production) and downstream (purification) processes. For testing purposes, the bioprocess is comprehensively mapped, from production, purification, and analytics to high-throughput detection of impurities such as DNA (hcDNA) and protein (HCP). The use of different cultivation formats, clarification strategies, and chromatography methods provides a broad data basis..

Impact

AAVeritas provides the foundation for AAV-based CMC projects. With the gained knowledge and the established production and analytics platforms, new AAV vectors and bioprocess optimizations can be tested quickly and efficiently. The GMP-oriented analytics approach ensures the production of pure products at high throughput through automation.