WHITEPAPER – Accelerated API Manufacturing by Combining Early-Stage and Late-Stage Process Development

Manufacturing Phase 1 clinical material in as little as 12–16 months

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. Please click here to download/view the entire whitepaper.