Varda's mission leverages decades of NASA's space station research to find and develop novel drug forms and formulations in microgravity. Processing in microgravity eliminates factors like natural convection and sedimentation, leading to improved crystal order, tunable particle size distributions, and new forms that can enhance the bioavailability, extend shelf life, create new intellectual property, and introduce new routes of administration. Compared to land-based methods, drug development and manufacturing in microgravity offer additional benefits by enabling crystal nucleation and growth to differ and by producing alternative drug forms or better amorphous material. However, limited access to space has hindered commercial drug development and manufacturing. Varda's talk will focus on designing and testing autonomous cooling crystallization, antisolvent crystallization, and melt/quench technologies, operating outside the constraints of crewed spacecraft. Preliminary ground-based results using model compounds such as L-histidine, indomethacin, and ritonavir demonstrate that the customized crystallization hardware can withstand pre-launch, launch, and re-entry.
Learning Objectives:
Understand how gravity, especially microgravity, can help pharmaceutical companies develop novel drug polymorphs and formulations to de-risk clinical development projects, enable new routes of administration, improve purity and bioavailability, and enhance patient compliance.
Discover how the culmination of 50 years of therapeutic crystallization achievements onboard space flights, paired with modern advancements like SpaceX's invention of the reusable rocket, is propelling microgravity-driven drug crystal form innovation into a commercially viable realm.
Dive into the exploration of the gravity variable (0-5g) and its revolutionary potential in pharmaceutical science, underscored by a blend of terrestrial and orbital experimentation alongside modeling.