(355d) Leveraging Microgravity to Achieve Elusive Crystallization Objectives

Varda's microgravity mission builds on decades of NASA space station research to develop and manufacture small molecules and biologics in a microgravity environment.

Processing in microgravity eliminates factors like natural convection and sedimentation, leading to tunable particle size distributions, improved crystal order, and new forms that can enhance bioavailability, extend shelf life, create new intellectual property, and introduce new routes of administration.

Drug development and manufacturing in microgravity offer other advantages over land-based methods by allowing crystal nucleation and growth to differ and by enabling the crystallization of the most stable drug form or creating amorphous samples. However, limited access to space has hindered the use of microgravity for commercial drug development and manufacturing.

Varda's talk will discuss the design and testing of autonomous cooling crystallization, antisolvent crystallization, and melt/quench technologies, operating within the constraints of an uncrewed spacecraft set to fly in 2023. Preliminary ground-based results using model compounds such as L-histidine, indomethacin, and ritonavir, including stability studies, demonstrate that the customized crystallization hardware can handle pre-launch, launch, and re-entry conditions.