Holistic Polymorph Screening - Identify the Lead Crystal Form and Accelerate CMC Progress

Small-molecule APIs frequently present multiple solid forms, making early form selection pivotal. Inadequate understanding at this stage elevates CMC, manufacturability, IP, and clinical risks—especially under tight timelines and limited API. We outline a hypothesis-driven screening strategy that maps the polymorphic space, establishes relative stabilities (including hydrates/solvates), and generates solubility–stability data to define a robust crystallization route. Aligned with ICH and major agency expectations and designed to surface patentable forms, this approach enables confident lead-form selection, reduces late-stage conversion risk, and clarifies operating space for scale-up and tech transfer.