Immunological and biological characteristics of recombinant human thyrotropin

Analyses of epitopes and biological activity were made on two preparations of recombinant human thyrotropin produced in Chinese hamster ovary cells. Seven monoclonal antibodies recognizing four epitopes on alpha subunit of hTSH (hTSH alpha) and three on beta subunit (hTSH beta) were used for the analysis. Binding activities of the two rhTSH with each antibody were almost identical with that of a pituitary-derived reference hTSH, except at one epitope on hTSH alpha. Their immunoreactivity measured by four commercial immunoassay kits and their bioactivity by thyrotropin dependent FRTL-5 cell system, however, agreed closely with those of the reference hTSH. From these results and its constant availability, rhTSH will be a good candidate for a future standard material in assays for hTSH.