(347c) ACP: Advanced Crystallization Platform

In this talk, we will present on the development of a platform we call the Advanced Crystallization Platform (ACP) for antisolvent-cooling crystallization process development and optimization at Amgen. This platform is designed to streamline crystallization process development by integrating real-time monitoring via calibrated PAT, automation, and control capabilities. We will describe the methodology used to establish the solubility surface for a given system, across the relevant solvent-antisolvent ratios and temperatures, as well as the PAT calibration and signal processing strategy that enables robust real-time monitoring of the relevant solution- and dispersed-solid-phase properties. We will also detail the lab-automation used to execute crystallizations in an iterative way, first interrogating the path-dependent dynamics and then optimizing for given crystallization objective. Such a system will be demonstrated for crystallization development with real use-cases in synthetic drug substance manufacturing.