Accelerated API Manufacturing By Combining Early-Stage And Late-Stage Process Development

Traditionally, early-stage and late-stage process development has been conducted separately, with early-stage focusing on material production and late-stage on process intensification. However, as more molecules in development receive orphan or fast-track designations, the conventional linear development approach can become counterproductive and costly, particularly when resources are invested in perfecting a process before achieving early clinical phase success. Integrating aspects of late-stage process development during the initial stages can save valuable time following phase 1 clinical studies.

The pharmaceutical landscape has shifted in recent years, with some small molecule drug products reaching the market shortly after discovery. Fast-track and orphan drugs, as well as high-potency oncology medications, are typically low-volume, high-value treatments where accelerated timelines and rapid market entry are crucial for success. Fast-track drug substances often progress from early-phase clinical studies to commercialization in about one-third the time required for other small molecule drugs.

This urgency pressures drug companies and their CDMO partners to produce phase 1 material within 12–16 months, depending on the molecule's complexity. This white paper outlines key considerations during early-stage development to avoid common pitfalls and expedite the transition from molecule to market.