M. Mulligan, S. Tuma, A. Wilson, K. Savin
Redwire,
United States
Keywords: Seed Crystals, Microgravity, Drug Manufacturing
Summary:
Pharmaceuticals in general, both small and large molecule drugs, often are best formulated as crystals. The crystalline state is the most stable of matter. Small and large molecule drugs both suffer from polymorphism and size coefficients of variation that are too large. While Some drugs can overcome these issues and make it to market many more cannot and fail to make it to market. A potential solution to these problems was seen in the result found 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, 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, improve manufacture of the product and lead to new intellectual property protections that extend the products life. Additionally, creating these drugs in microgravity with greater crystalline uniformity and less variation in size allows for new polymorphs to be found, for more uniform drugs with less waste in the process of making the drugs, and possibly lead to new methods 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 products worlds. The Pharmaceutical In-space Laboratory (PIL) proposes to be the first suite of hardware that can not only crystallize small and large molecule drugs but can track the process with real time video using dynamic microscopy. Redwire flew 28 PIL-BOXes and 17 compounds in one year to the ISS for making seed crystals for terrestrial drug manufacturing. These flights are all part of Redwire’s legacy and more than thirty year heritage as a research payloads provider from the space shuttle era, to the International Space Station (ISS), and beyond.