ABSTRACT
Assessment of Biologicals ............................................................................ 158 6.7 Summary ...................................................................................................... 160 References .............................................................................................................. 161
The emergence of and continuous advancement in recombinant DNA (rDNA), hybridoma, and cell culture technologies has led to an escalating production over the past 20 years of biotechnology-derived therapeutics (therapeutic proteins or biologicals) for use in various clinical indications. Biologicals are protein pharmaceuticals derived from living organisms and are distinguished from conventional (small molecule) pharmaceuticals by their manufacturing processes (biological sources vs. chemical/synthetic processes). Thus, the definition of biologicals encompasses protein therapeutics such as recombinant human proteins (i.e., cytokines and replacement enzymes) and monoclonal antibodies.1 Although vaccines and cell and gene therapy products can also fall under the definition of biologicals, these products have distinctive properties that distinguish them from biotechnology-derived therapeutics, and they will not be discussed in this chapter.
