Considerations of manufacturability for AAV based gene therapy products for rare diseases

Passage Bio is developing a robust and efficient manufacturing platform to streamline the development and technology transfer of preclinical and clinical candidates to external manufacturing partners. In this presentation, we highlight Passage Bio’s approach to manufacturability for AAV vectors by advancements in cell line development, optimizing process conditions, implementation of next generation analytics, and viral clearance strategy to ensure a safe and efficacious final product. It is our goal that this work will result in a state-of-the-art process for AAV production to facilitate rapid transition toward pre-commercial development and build out a robust gene therapy pipeline