Traditional sterilization methods have long been incompatible with biotherapeutics. Supercritical CO2 has entered the space as an alternative solution that offers a variety of applications for the pharmaceutical industry including sterilization, extraction, and impregnation of bioactives.
NovaSterilis has a long history of developing terminal sterilization solutions for small molecule therapeutics (“APIs”) with no functional impact to physical properties or biological functions. Unlike EtO, Supercritical CO2 can be used to sterilize biotherapeutics/APIs in solution, as well as in a lyophilized state.
Beyond terminal sterilization, NovaSterilis has developed a process to extract residual ethylene oxide trapped within finished products left behind after EtO sterilization. This process allows currently approved therapeutics to be sold in markets where regulations require residual EtO to be below a threshold which, historically, they have been unable to achieve with conventional outgassing techniques.
Large molecule therapeutics (biologics and vaccines) have been a focus of NovaSterilis’ development efforts. NovaSterilis has developed multiple processes for not only the sterilization of large molecule therapeutics, but it has also developed processes for the creation of vaccines. NovaSterilis is looking to grow the number of active partnerships in this market.
In an emerging area of research, NovaSterilis has merged small molecule therapeutics with sterilized endospore delivery vehicles for the targeting of anaerobic solid tumors. A research partner is being sought for the next stage of research activities.
Areas of research and development in the Therapeutics Market:
- Creation of vaccines
- Sterilization of biologics/vaccines
- Extraction of ethylene oxide from APIs
- Endospore impregnation with therapeutics for solid tumor targeting