Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development. It also calls for collaboration across several teams in order to break down the silos that can interrupt the flow of open and clear communication.
With patient care at the forefront, it is critical to assess the economics of both outsourcing models and ensure that the one you select provides the most efficient path to commercialization. This was the purpose of a recent study by the Tufts Center for the Study of Drug Development (CSDD), which compared cycle times and development economics between multi- and single-source CDMO models.
Ensure that you always have the exact resources and expertise you need, especially for your most difficult-to-manufacture compounds. Reactors ranging from 30 L up to 16 m3, comprehensive analytical services and expertise in all the chemistries you expect, as well as many unique solutions and innovative technologies you won’t find anywhere else.