Kenneth Savin, Redwire, Indianapolis, IN
Redwire’s heritage efforts have included manufacturing prototypes and science enablers for individuals doing work in orbit and can find their foundation in work performed on Space Shuttle missions starting over 30 years ago. A recent focus for us has been the systems that facilitate the development of pharmaceutical crystals.
In general, both small and large molecule drugs, are often best formulated as crystals. The crystalline state is more easily handled, isolated and is relatively stable but can suffer from polymorphism and size coefficients of variation that are too large. A potential solution to these problems was impressed upon us by the result found in the microgravity enabled crystal growing experiment of the monoclonal antibody, Pembrolizumab marketed by Merck as the product, Keytruda. Creating new forms and potentially improving the existing forms of drugs in microgravity with greater crystalline uniformity and less variation in size allows for new polymorphs could lead to faster development times, less waste in the process of making the drugs, and possibly lead to new modes of delivery.
We will present results demonstrating the difference in crystals formed terrestrially vs those generated on the International Space Station Platform and describe the use of those crystals for future terrestrial production of pharmaceuticals.