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When a drug substance requires a parenteral formulation to administer it, there are key factors to consider when choosing the ideal CDMO partner.
Traditionally, early-stage and late-stage process development have been done separately, with early-stage mostly focused on material production and late-stage on process intensification. As more molecules in development fall under an orphan or fast-track indication, the traditional approach of linear development stages can be counterproductive—not to mention expensive—due to investing resources in perfecting a process prior to early clinical phase success. Addressing some of the aspects of late-stage process development during the initial process development can help save valuable time following phase 1 clinical studies.