ABSTRACT
Although there are many books and reviews written on the development of methods for quantitating peptides and proteins in clinical chemistry, these are written for analytes that are determined over the normal range observed in humans (1 -.4). The development of immunoassays to analyze recombinant proteins and pep tides in nonclinical and clinical studies has been an extraordinary learning curve for us with many parameters of assay develop ment being discovered by trial and error, sound experimental design and by serendipity (5). In drug development of protein pharmaceuticals, it is necessary to determine the concentration of the admin istered product in physiological fluids which may contain endogenous identical or cross-reacting proteins or binding pro teins which can interfere with quantitation of the administered product. In addition, it may be necessary to quantitate very low concentrations requiring assays of high sensitivity. The scopc of this chapter is to provide some of the insights that we have gathered over several years in supporting these studies.
