Crystal Pharmatech provides end-to-end oral solid dose development, injectable, lipid-based formulation development, and clinical manufacturing under one roof—seamlessly uniting enabling technologies for insoluble drugs (spray-dried ASDs, hot-melt extrusion, lipid and nano platforms) with conventional and mini-tablet processes (direct/wet/dry granulation, bi-layer, IR/CR). Chosen to compress tech transfer and de-risk timelines, the program takes you from raw API to Phase I drug product on a single, coordinated plan, supported by full analytical/QC, packaging and labeling, and temperature-controlled global clinical-supply logistics with regulatory CMC support across US/EU/CN.
Our technology platform includes GEA PSD-1 spray dryer, Leistritz HME, Glatt fluid bed, Alexanderwerk roller compactor, Korsch compaction/tablet systems, and a solid-state analytics suite (e.g., Rigaku 9 kW XRPD, inVia Raman, SMS DVS). The integrated footprint—Suzhou (China), Cranbury/Pleasanton (USA), and Mississauga/Toronto (Canada)—enables regional execution, rapid iteration, and smooth site-to-site transfer from bench to clinic. Typical outcomes include IND-ready capsules or tablets in as little as ~6 months and ~8-week end-to-end clinical-supply runs, with consistent quality, fewer handoffs, and a complete cGMP data package to support filings.
