Biomolecules versus smaller chemicals in toxicology

Abstract

For many life-science professionals, biological products represent the cutting edge of medical research and are the smartest means to target and treat a variety of disease and conditions for which the current treatments are still unsatisfactory. In contrast to new chemical entities (NCE), most biologics are complex mixtures that are not easily identified or fully characterized. Nevertheless, due to the rapid development of biotechnology in the last three decades, the number of approved biological drugs is increasing at a faster rate than it is the case for new chemical entities. Biological drugs may be highly specific for a target, are more heat sensitive and susceptible to microbial contamination, and are likely antigenic. Thus, the quality and security testing of biologics is becoming increasingly important. This chapter compares the regulatory environment relevant for biological drugs, with a typical “case-by-case” development program versus NCEs, which are generally developed according to a more standard “classical” manner.