Development and Maintenance of Critical Reagents for Ligand Binding Assays to Support Regulatory-Compliant Bioanalysis

The FDA approved the first biotherapeutic (synthetic insulin) in 1982. Thirty-five years later, this novel class of pharmaceuticals has improved the quality of life for millions of individuals. While drug discovery of biotherapeutics and biosimilars was originally dominated by small biotechnology companies, today nearly every major pharmaceutical company in the world is engaged in this effort. Biotherapeutic programs present unique challenges to drug development, including generating supportive data to demonstrate safety and efficacy in the target population. Bioanalysis of traditional chemical pharmaceutics may be achieved after organic extraction from biological fluids, thus removing potentially interfering substances. Furthermore, strategic decisions based on the structure of the molecule often facilitates the development of an analytical method utilizing sensitive mechanical instrumentation. Biotherapeutics are often composed of amino acids whose functionality depends on complex structure. These compounds are measured via protein-protein interactions requiring unique reagents for each drug program. In this chapter, we describe these interactions and focus on the importance of generating and maintaining high-quality reagents, a process known as reagent lifecycle management .