The process combining supercritical CO2 and co-sterilants produces strong synergistic microbicidal effects in relatively mild conditions. The mechanism of microbe inactivation is not well characterized, but the disruption of lipid membranes and mild oxidative damage appear to be involved. The process, which is also highly efficient against viruses, is considered to be very mild compared to other sterilization methods. Experimental evidence shows that damage to protein is limited, and that immunogenic epitopes can survive the process. In this project NovaSterilis will seek to optimize the supercritical CO2 sterilization process for broad and effective virucidal treatments while attempting to maintain the integrity of model proteins. The first goal is to fully validate the supercritical process against viruses as a method that could replace ?-radiations which fail at effective virus inactivation and damage sensitive products. The second goal will be to characterize and optimize the supercritical sterilization process for the sterilization of proteins. Proteins have become increasingly popular as vaccines, therapeutics, and in combination devices. Yet, their sterilization remains extremely challenging. In collaboration with the group of Bryce Chackerian at the University of New Mexico, and Dr. Stephen Eyles and Professor Igor Kaltashov at UMass-Amherst, the effect of supercritical sterilization on growth factors and recombinant vaccines will be studied with in vitro and in vivo functional assay, and will for the first time use state-of-the-art mass spectrometry to determine with great precision the effect of scCO2 itself or combined with a sterilant on the conformation and oxidation status of model proteins.

Public Health Relevance

There is a clear need for a gentle and non-toxic method for effective bacterial and virus inactivation in labile products such as drugs, vaccines, therapeutic proteins, combination devices and tissue allografts. Supercritical carbon dioxide combined with a peracetic acid co-sterilant has the potential to significantly improve the drug, medical device and tissue industries' ability to offer products with guaranteed final sterility. The project will seek to optimize this sterilization process against viruses and minimize damage to proteins.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AI120282-03
Application #
9413982
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Park, Eun-Chung
Project Start
2015-07-01
Project End
2018-12-31
Budget Start
2018-01-01
Budget End
2018-12-31
Support Year
3
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Novasterilis, Inc.
Department
Type
DUNS #
129172727
City
Lansing
State
NY
Country
United States
Zip Code
14882