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OneXpress Case Study – Enabling Successful SDD Scale Up

Summary: A virtual biotechnology company, focused on the development and commercialization of a product to treat advanced solid tumors, partnered with Catalent for the development, clinical trial supply and scale-up of a spray-drying program. Catalent’s early development center of excellence in San Diego developed a spray drying process for the client and supplied clinical trial material for their phase 1 and 2 studies. To supply upcoming phase 2/3 studies, Catalent efficiently transferred the program to its state of the art late phase and commercial spray drying site in Haverhill, U.K. Catalent deployed its integrated OneXpress® Solution to expedite the transfer of this program to the late-stage manufacturing site while optimizing the utilization of a limited supply of API.​

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