K. Savin, M. Mulligan, S. Tuma
Redwire,
United States
Keywords: microgravity, crystallization, pharmaceutical form
Summary:
In order to enable a thriving Low Earth Orbit (LEO) economy, there is a push to do more research leading to manufacturing in LEO with fewer flights. The Redwire Pharmaceutical In-space Laboratory (PIL) aims to do just that. In recent years, the push to find new polymorphs and improve crystalline uniformity for the pharmaceutical industry 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 PIL family of hardware 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. PIL also is capable of making a small quantity of seed crystals that can be used to create large quantities of crystals terrestrially – making PIL the first step to a manufactured product in space for terrestrial use. 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. The lack of sedimentation and convection in microgravity is what allows this unique environment to be used to create a better crystal than what can be produced terrestrially.