This Small Business Innovation Research (SBIR) Phase I research project aims to develop a novel method for the production of whole cell vaccines using the supercritical CO2 technology. The majority of current whole cell vaccine preparations are made using formalin inactivation which has numerous drawbacks including residual formaldehyde, denaturation of key antigens, and lack of sterility requiring preservatives. Supercritical CO2 inactivation of leaves no toxic residuals, does not denature proteins, and is inherently sterile.
Commercially, the application is a production process for a higher quality vaccine which may require fewer doses as well as open the door to the quick and inexpensive manufacture of vaccines to emerging diseases for which current methodologies do not create useful vaccines, or where these methods are not cost-effective given a small financial return. In addition to the production of new vaccines the sterilization of existing subunit vaccines using this technology will reduce the need for preservatives and increase the safety of vaccine preparations. Both companies and the public health will benefit from safer, higher quality, and less expensive vaccine preparations.
