By Dr. Stephanie Kosnik, Boehringer Ingelheim

Spherical Crystallization (agglomeration) is an emerging and versatile technique in the field of particle design, which transforms crystals into compact, free-flowing, and easily processable spherical agglomerates. This technique is particularly useful for molecules who crystallize in problematic morphologies such as needles, which in turn can lead to problems with mixing, isolation, and downstream API processing.  In this presentation, an overview of our approach to implement spherical crystallization for both complex intermediates and final APIs is described, including how this process can be scaled up reliably to pilot plant scale, and how polymorph control can be maintained throughout the process.