Lu Niu

Crystal Pharmatech is a science-led CRO/CDMO for small molecule drug development — from solid form selection and preformulation through formulation development and GMP clinical supply. Since 2010, we have supported more than 4,000 compounds for pharmaceutical and biotechnology partners worldwide. We start with solid form science. Polymorph, salt, and cocrystal screening, crystallization process development, and developability assessment establish — from data rather than assumption — whether a molecule will succeed as a crystalline solid or requires an enabling formulation. Our containment capability extends this work to highly potent compounds up to OEB5, a constraint that excludes many solid-state laboratories from oncology programs entirely. For poorly soluble compounds, we develop amorphous solid dispersions by spray drying and hot-melt extrusion, from polymer and process screening through scale-up and GMP manufacture. That capability matters most for molecules outside conventional chemical space — PROTACs and other targeted protein degraders, and oral peptides — where solubility and permeability determine whether an oral product is possible at all. Solid-state data, formulation design, and the manufacturing process stay with one scientific team, so early decisions carry forward rather than being rebuilt at each handoff. We operate formulation GMP manufacturing in Suzhou, China and Toronto, Canada, and solid-state and preformulation laboratories in Suzhou, China and Cranbury, New Jersey — giving sponsors real choice in where their programs are executed, under consistent quality systems and a First-Time-Right approach. Crystal Pharmatech is part of Crystal Group, alongside Crystal Bio Solutions (GLP bioanalysis, clinical pharmacology, and biologics CMC analytical) and Crystal NAX (nucleic acid therapeutics).