Five Hidden Risks In Early-Phase OSD Formulation Development

Formulation decisions made during early-phase OSD development often look sound at the time. The problems tend to emerge later, when scalability demands, stability data, or regulatory review expose gaps that earlier choices left unaddressed. Five recurring risk areas drive a disproportionate share of preventable delays in OSD programs: API complexity, excipient compatibility, scalability assumptions, stability planning, and regulatory readiness. Each represents a point where teams commonly underestimate long-term consequences in the interest of reaching first-in-human milestones.

The article outlines where these risks tend to originate and how development teams can plan more effectively at the outset, before compounding decisions narrow their options. Explore the analysis to identify where your program may be most exposed.