Case Study: Risk Mitigation

The Challenge: Our client had received an emergency use authorization for their product from the U.S. FDA. Speed to production to meet this urgent increase in demand was critical. Patheon was chosen for the project based upon our readily available capacity and resources, as well as our expertise in sterile production.

The Solution The first step was to immediately transfer, qualify and validate the product to the Patheon Ferentino plant for the emergency use supply. In parallel a second site, the Patheon Monza facility, was qualified to ensure a robust commercial supply moving forward.