NovaSterilis, a pioneer in medical device sterilization using supercritical carbon dioxide (“scCO2”), has been awarded a $1.75 million SBIR (Small Business Innovation Research) Phase II grant by the NIAID (National Institute of Allergy and Infectious Diseases). This funding furthers the development of NovaSterilis’ scCO2 terminal sterilization platform for the pharmaceutical and biotechnology industries. This effort will extend the work NovaSterilis has done through the Food and Drug Administration’s Innovation Challenge 1 program (FDA Innovation Challenge) to reduce the industry’s reliance on ethylene oxide sterilization by identifying alternative sterilization technologies.
This award follows the successful completion of the $242,000 initial phase of the Fast Track SBIR grant for which drug substance compatibility was assessed and the minimal process conditions for achieving a sterility assurance level (SAL) of 10-6 were determined. NovaSterilis has consistently demonstrated its leadership in the utilization of scCO2 in the medical device and regenerative medicine industries. Through NovaSterilis’ efforts, scCO2 sterilization has been included in multiple devices cleared by the FDA and other governing bodies around the globe.
As biotech and pharmaceutical industries seek advanced sterilization methods that preserve functionality and compatibility with emerging therapeutics, including combination devices, NovaSterilis is well positioned to leverage its previous successes in the use of scCO2 sterilization to meet their requirements. There is a growing demand around the globe for novel terminal sterilization alternatives to aseptic manufacturing and ethylene oxide sterilization.
The $1.75 million grant from NIAID will allow NovaSterilis to develop novel modifications to its existing scCO2 sterilization process, which will allow for terminal sterilization without negatively impacting the functionality of large or small molecule therapeutics. Additionally, the grant will support elements of the regulatory work necessary to move scCO2 sterilization from a novel sterilization method to an established method at the FDA.
Tony Eisenhut, CEO of NovaSterilis, emphasized the company’s commitment to improving patients’ lives in partnership with manufacturers, stating, “This grant allows us to leverage our past achievements in a way that benefits biotech and pharmaceutical manufacturers as well as contract sterilizers. We look forward to building new partnerships that will allow us to optimize scCO2 sterilization in a way that benefits both their customers and the environment.”
NovaSterilis will utilize its experience collaborating with regulatory bodies in a way that ensures its innovative terminal sterilization technology aligns with evolving industry standards. The company aims to provide pharmaceutical manufacturers with a reliable, efficient, and environmentally sustainable alternative to ethylene oxide sterilization while meeting the demands of both regulatory compliance and patient safety.
Disclosure: Research reported in this press release is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R44AI170431-02. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About NovaSterilis: NovaSterilis is a leading innovator in supercritical carbon dioxide technology, dedicated to advancing environmentally friendly and efficient solutions for a wide range of applications, including tissue processing, sterilization, and decellularization of regenerative medicine matrices. With a commitment to sustainability and innovation, NovaSterilis aims to transform industries and improve lives through the power of supercritical carbon dioxide. For more information visit http://www.novasterilis.com
Lansing, NY, Feb 23, 2024