原料药中试厂的规模化秤量分析技术的威力

Several applications of PAT at scale are provided. In one project, FTIR calibration models were developed in the lab to provide a reliable method for measuring the kinetics of what appeared to be a consecutive series reaction. The study led to incorporating an autocatalytic step in the mechanism to accurately predict the kinetics. The lab calibration models were applied to the FTIR trends from the API pilot plant, yielding quantitative predictions in excellent agreement with the expected values and the trends demonstrated scalability of the reaction.

Crystallization is another key API unit operation that also benefits from online PAT monitoring. FBRM tracking of particle chord lengths is valuable as an indicator of wet milling performance, as well as, crystallization progress. FTIR is often valuable for tracking the species concentration to confirm de-supersaturation and monitor crystallization progress. Particle vision systems are expected to provide even more benefits in the future. Raman spectroscopy was used to monitor the humidified drying of an API with dihydrate and trihydrate polymorphs, while mass spectrometry is useful for indicating drying endpoints. Using PAT in a GMP Pilot Plant required overcoming some unique challenges, and these aspects are also addressed.

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