Gene therapy manufacturing is a critical factor in the successful development and commercialization of novel genetic medicines. As such, Passage is establishing dedicated GMP production capacity capable of meeting production requirements for our current lead product candidates through early commercialization.

We have an established relationship with Paragon, a contract development and manufacturing organization (CDMO) for our initial manufacturing needs. We have selected iCELLis, a well-characterized production platform that has been used for both commercial and clinical AAV products and product candidates, for the development of our candidates. This fully-integrated bioreactor system can support clinical and commercial-scale volumes and provides excellent cell growth conditions for adherent cells.

In addition to our dedicated cGMP suite, we have access to broad and deep early-stage process science capabilities and experience to enable technology transfer of scalable processes to our CDMO, and state-of-the art analytical capabilities for product quality testing and analytical characterization as part of our partnership with GTP. GTP currently provides us with the preclinical toxicology research-grade vector supplies, while Paragon will provide us with the cGMP AAV clinical supplies for our clinical trials, following a technology transfer process from Penn to Paragon.