Rapid, Large-Scale Production of Full-Length, Human-Like Monoclonal Antibodies

Abstract

Current recombinant protein production systems require several months to develop.Existing systems fail to provide timely, flexible, and cost-effective therapies to protect against emergency mass-casualty infections or poisonings. As the identity of many new biological threat agents are unlikely to be known in advance, pre-emptive manufacturing and stockpiling of countermeasures cannot be performed. Preparedness for a biological catastrophe requires a radical solution to replace the current slow scale-up and manufacture of lifesaving medical countermeasures. Subunit vaccines and antibody fragments may be produced in bacteria, yeast, plant or insect cells. However, generation of full-length, human like glycosylated antibodies requires mammalian cell culture due to the cell's ability to carry out complex assembly and processing. Although commercial cell culture methods for antibody production from stable gene expression have been substantially improved over the last 30 years, the time required to achieve full scale production for a new product is too long for a rapid, emergency