The purpose of the Biologics Production Shared Resource is fourfold: (1) to develop and optimize production of biologic agents in the most cost-effective manner possiblel (2) to optimize methods of purification of biologic agents at high yield; (3) to develop, evaluate and maintain quality control standards for biologic agents intended for intravenous administration in humans and (4) to provide investigators with monoclonal antibodies and other therapeutics in both quantity and form suitable for intravenous administration in humans. Resource activities focus on production and purification of purified antibodies and other cell culture derived products in amounts ranging from milligrams to grams with concomitant support to meet both research and U.S. Food and Drug Administration (FDA) requirements. This application requests continued support for a resource which continues to fulfill an essential role for peer reviewed research within the Consortium.
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