M. Mulligan, K. Savin, S. Tuma
Redwire Corporation,
Keywords:
Pharmaceuticals in general, both small and large molecule, often are best formulated as crystals. Small and large molecule pharmaceuticals can both suffer from polymorphism and large size coefficients of variation. While some products can overcome these issues and make it to market, many more do not. A potential solution to these problems was observed in the microgravity enabled crystal growing experiment of the monoclonal antibody, Pembrolizumab marketed by Merck as the product, Keytruda. In on-orbit crystallization studies of Keytruda, by the researcher Paul Reichert, produced crystals with significant uniformity (something that could not be done on Earth where mixtures of crystals are produced) and size coefficients of variation below ~8%. These crystals could then be used as seeds to create new crystals terrestrially that could provide the product material with new properties. Additionally, creating these seeds in microgravity could lead to new polymorphs and more uniform crystalline products leading to improvements in production and new modes of delivery. In recent years, the push to find new polymorphs and improve crystalline uniformity have become a major focus for scientists and engineers not just in the pharmaceutical and biotechnology industries, but also the agricultural, food, and body care product worlds.2 The Pharmaceutical In-space Laboratory (PIL) proposes to be a hardware solution that can not only crystallize small and large molecule drugs but can track the process with real time video using dynamic microscopy.