Opportunities and Challenges of Therapeutic Monoclonal Antibodies as Medical Countermeasures for Biodefense

Abstract

Antibodies, naturally produced in the body as part of the immune response to infectious agents, can also be introduced artificially to treat infectious diseases. Advances in biotechnology in the last decades have made human or humanized monoclonal antibodies (mAbs) as therapeutics possible. These therapeutic mAbs currently enjoy unprecedented success and recognition of their potential. Unlike vaccines, therapeutic mAbs can confer instant and consistent protection against bio-threat agents when administered regardless of the recipient’s immune status. Therapeutic mAbs can be administered in higher levels than those elicited by vaccines, and thus provide a higher level of protection or treatment that is necessary in a biological attack where people are exposed to a higher exposure of agent concentration than that found in nature. Furthermore, therapeutic mAbs have substantial advantages over antimicrobial drugs, such as high specificity, low systemic toxicity, relatively long half-life, and no concerns over disrupting the body’s microbiome. Therapeutic mAbs can be used for both pre- and post-exposure protection; therefore, they have great value as effective medical countermeasures (MedCMs) against bio-threat agents. However, there are still some challenges to be overcome before therapeutic mAbs become ideal MedCMs against bio-threat agents. In this review, both opportunities and challenges in development of therapeutic mAbs are discussed.