Does the manufacturing process for Monoclate-P® include viral elimination/reduction steps?
A. Yes. Monoclate-P® is pasteurized, heating in aqueous solution at 60°C for 10 hours. This method of viral inactivation has demonstrated reduction of both lipid-enveloped viruses (such as hepatitis B and C, HIV, and herpes viruses) and certain non-lipid-enveloped viruses (such as hepatitis A, parvo B19, and polio) in validation experiments. The patented monoclonal antibody (MAb) immunoaffinity chromatography purification process is designed to help eliminate viruses. In this process, murine antibodies specific to a single target protein (such as factor VIII) are placed in a chromatography column. When plasma is passed through the column, the antibodies bind the target protein; extraneous proteins (such as viruses and unwanted clotting factors) pass through. In over 10 years, and more than 1 billion units infused, there have been no confirmed reports of viral transmissions with Monoclate-P®. As with all plasma-derived products, the risk of transmission of infectious agents, including v
