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ARS Home » Research » Publications at this Location » Publication #100305
Title: A UNIVERSAL VIRUS INACTIVANT FOR DECONTAMINATING BLOOD AND BIOPHARMACEUTICAL PRODUCTS

Author
item Brown, Fred
item MEYER, RICHARD - USDA-APHIS, FADDL, PIADC
item LAW, MICHAEL - FORMER PIADC EMPLOYEE
item Kramer Jr, Edward
item NEWMAN, JOHN-F - FORMER PIADC EMPLOYEE

Submitted to: Biologicals
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 10/19/1997
Publication Date: N/A
Citation: N/A

Interpretive Summary: Imines are used on a large scale for the production of inactivated FMD vaccines. These products have excellent immunogenicity and are used worldwide for the control of the disease. The imines appear to have little or no deleterious effect on proteins. Consequently, they have the potential to be used for "sterilizing" blood and blood products and may have application in the blood transfusion and pharmaceutical industries.

Technical Abstract: Removal of virus infectivity from blood and biopharmaceutical products prepared from blood is an issue of considerable importance. For biopharmaceutical products, removal can usually be achieved by a series of fractionation steps or by inactivation with a suitable reagent. Irrespective of the methods that are chosen it is vital that the biological activity of the product is not impaired. For blood and unfractionated plasma or serum, the problem is even more challenging. Selective inactivation of the genome is the key step in the preparation of killed virus vaccines. Viruses belonging to all the recognized families can be inactivated by imines. In this paper it is shown that the biological properties of several proteins, including the cell growth-promoting factors in calf serum, are not impaired using conditions which ensure the inactivation of > 10(15) infectious units of poliovirus and FMDV. Also shown is that both viruses can be inactivated by imines at 4C, thus providing a method for removing infectivity from protein preparations which are unstable at higher temperatures. The RNA extracted from FMDV inactivated at 4C was not degraded and contained no hidden breaks but nevertheless was non-infectious. However, it could be amplified by PCR using primers corresponding to the gene coding for a portion of the viral RNA polymerase but not from that coding for VP1 one of the structural proteins, showing that alteration of a base or bases had occurred in that region. Surprisingly, it could be translated in the rabbit reticulocyte system although some of the products were different from those obtained with unmodified RNA.