Optimization of Supercritical Carbon Dioxide Based Virus Inactivation, Characterized by Protein Damage and Maintenance of Epitope Integrity in Vaccine Sterilization

Information

  • Research Project
  • 9413982
  • ApplicationId
    9413982
  • Core Project Number
    R44AI120282
  • Full Project Number
    5R44AI120282-03
  • Serial Number
    120282
  • FOA Number
    PA-15-269
  • Sub Project Id
  • Project Start Date
    7/1/2015 - 10 years ago
  • Project End Date
    12/31/2018 - 6 years ago
  • Program Officer Name
    PARK, EUN-CHUNG
  • Budget Start Date
    1/1/2018 - 7 years ago
  • Budget End Date
    12/31/2018 - 6 years ago
  • Fiscal Year
    2018
  • Support Year
    03
  • Suffix
  • Award Notice Date
    12/14/2017 - 7 years ago
Organizations

Optimization of Supercritical Carbon Dioxide Based Virus Inactivation, Characterized by Protein Damage and Maintenance of Epitope Integrity in Vaccine Sterilization

Project Summary 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.

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    R44
  • Administering IC
    AI
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    431739
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    855
  • Ed Inst. Type
  • Funding ICs
    NIAID:431739\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    NOVASTERILIS, INC.
  • Organization Department
  • Organization DUNS
    129172727
  • Organization City
    LANSING
  • Organization State
    NY
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    148828906
  • Organization District
    UNITED STATES