Our Mission - Provide supercritical CO2 knowledge, services and tools to all companies focused on a healthier world.
Equipment for today's needs and R&D services for tomorrow's opportunities
Allograft to xenograft tissue market served as the commercial launch for NovaSteirilis. Today the Nova2200 and Nova8800 platforms clean and/or sterilize a variety of biomaterials including dermis, tendons, amnion, bone, hyaluron, collagen, cellulose, alginates and silk to name a few. The Nova Process achieves industry standard sterility assurance levels of SAL6 and has been the terminal sterilization modality of choice for devices approved by both the TGA and FDA.
Efforts in drug delivery and regenerative medicine have focused on combination devices; sensitive polymers with biologic factors or bio-scaffolds impregnated with a therapeutic. These devices are often manufactured aseptically because no terminal sterilization solution exists. Development efforts have centered on constructs such as heart valves, arterial conduits hyaluronic acid and bone crunch impregnated with bioactives and endospores inoculated with therapeutics for treatment of solid tumors.
The Nova Process has been vetted as a terminal sterilization modality on small molecule APIs with no impact to physical properties or biological function. Additionally, a process to extract residual ethylene oxide from finished APIs has been patented. Large molecule treatments are not only limited to sterility but it also included a process for the creation of vaccines. This is a focus area of development for NovaSterilis with a desire to grow the number of active partnerships.
As scCO2 becomes more widely recognized, and the low temperature, non-reactive, penetrating attributes of the material are better appreciated, envisioned applications have grown dramatically. Despite many materials being compatible with scCO2 it can cause problems with structure and function, so NovaSterilis has evaluated hundreds of materials as well as devices (combination materials) ranging from drug eluting polymers to single use syringes to multi-use, complex devices such as endoscopes.