General Competition (April 1992)

Low-Temperature Viral Inactivation

Sponsor: Aphios Corporation

• Project Performance Period: 7/1/1992 - 6/30/1995
• Total project (est.): $2,500,000.00
• Requested ATP funds: $2,000,000.00

The AIDS epidemic has highlighted a persistent concern in the health-care community: the need for effective sterilization techniques for human blood plasma, plasma-derived products, and intravenous biological products from recombinant-DNA or monoclonal antibody sources. In addition to HIV (the virus which causes AIDS), hepatitis and other infectious viruses represent serious threats to society. Several sterilization procedures (using heat, ultraviolet irradiation or a chemical agent, for example) are already in use, but there are drawbacks associated with each method. Aphios is pioneering a novel sterilization technology, critical fluid inactivation, based on gaseous substances such as carbon dioxide which are raised above their critical temperatures and pressures. In laboratory tests, these fluids exhibit a combination of liquid and gaseous properties, and have been shown to be effective in inactivating prototypical viruses. Critical fluid viral inactivation uses low temperatures and short process times. It therefore has a minimal impact on the product, and should scale well to production levels. The proposed research program will establish the virus inactivation mechanism of this technology, its effect on the biological activity of the proteins in biological fluids, and optimum process parameters, and will develop a laboratory prototype apparatus.

For project information:

Dr. Trevor P. Castor, (617) 932-6933

ATP Project Manager

Linda Schilling, (301) 975-2887
linda.schilling@nist.gov