This service unifies material-sparing FAST analytics, solid-state research, lab-scale crystallization development, and pre-formulation into a single early-development track that turns scarce API into decision-ready insight and scale-transferable processes. We start with focused solid-state testing to reveal form, stability, hygroscopicity, and manufacturability risks quickly, using only the highest-value assays across diffraction/spectroscopy (e.g., XRPD, SCXRD/MicroED, FTIR, Raman), thermal/moisture analysis (DSC/mDSC, TGA, DVS/KF, hot-stage PLM), morphology/particle characterization (PLM, SEM, PSD, BET), and core chemistries (ssNMR/qNMR, HPLC/GC, pKa, logP/D). Those results feed crystallization development, where solvent/solubility mapping, seeded nucleation for form/enantiomer control, and PSD/habit tuning generate high-purity material and define CPPs and scale-ready parameters. In parallel, pre-formulation converts physicochemical and biorelevant dissolution data into an evidence-based plan—selecting salt/form or enabling technologies (e.g., ASD, HME, lipid, nanosuspension), establishing preclinical vehicles, and, when needed, linking to PBPK to project first-in-human dose. The outcome is a concise, go/no-go package that includes: recommended crystal form with risk matrix and structure lock-in options, crystallization route with transfer-ready ranges, formulation starting points with exposure rationale, and prioritized next steps. Sponsors choose this integrated pathway to de-risk stability, bioavailability, and manufacturability early; compress timelines; and hand off robust material, methods, and rationale to downstream CMC and GMP teams.
