By Frederic Baudry, API Director, Valdepharm, Fareva and James Faust, Director, API Business Development, North America, API Division, Fareva
A few years ago, Fareva entered into discussions with an innovator that was single sourced for a highly specialized, spray-dried API quickly moving toward an NDA filing after very positive clinical trials. The sponsor needed to ensure a continuous supply of the API, but being single sourced highlighted a limitation in their supply strategy should volumes grow or unforeseen supply interruptions occur. Due to the unique physical properties of their API, the sponsor believed that there could be campaigning advantages with a Hastelloy spray dryer. Unable to find a suitable existing unit but needing to establish a dual-source supply chain for a key product, the sponsor sought to find a high-quality CDMO willing to oversee the design, construction, and installation of specialized equipment. The sponsor needed to find a partner who would support the project from R&D to submission and to commercial supply.