As one of the oldest unit operations known to mankind, crystallization today is a leading method for efficient isolation of drug substances with high purity and desired solid state characteristics, to ensure efficacy and safety of drug products. Nevertheless, timely development of robust crystallization processes for either small molecule or protein drugs presents many challenges. It is very common for crystallization processes of drug substances to face irrobust control of product quality attributes upon scale up or during manufacturing.
Effective discovery and isolation of potential solid forms (e.g., polymorphs, salts, hydrates/solvates, cocrystals) of new drug compounds are also in high demand for timely selection of the right solid form with feasible physical-chemical properties. At J-Star Research, we combine expertise required (e.g., listed below) for successful development of crystallization processes and effective solid form screening, to meet the ongoing demands of pharmaceutical clients around the globe.