Process and operations strategies to enable global access to antibody therapies.

Abstract

Few monoclonal antibodies are currently approved for treating infectious diseases, but multiple products are in development against a broad range of infectious diseases, including Ebola, influenza, hepatitis B, HIV, dengue, and COVID-19. The maturity of mAb technologies now allow us to identify and advance neutralizing mAb products to the clinic at "pandemic pace", as the pipeline of mAbs targeting SARS-CoV-2 has demonstrated. Ensuring global access to these products for passive immunization, however, will require both low manufacturing cost and multi-ton production capacity-particularly for those infectious diseases where the geographic burden falls mostly in low- and middle-income countries or those with pandemic potential. Analysis of process economics and manufacturing technologies for antibody and other parenteral protein therapeutics demonstrates the importance of economies of scale to reducing the cost of goods for drug substance manufacturing. There are major benefits to convergence on a standardized platform process for antibody production that is portable to most existing very large-scale facilities, carries low risk for complications during process transfer and scale-up, and has a predictable timeline and probability of technical and regulatory success. In the case of an infectious disease with pandemic potential which could be treated with an antibody, such as COVID-19 or influenza, these advantages are paramount.