Baculovirus-insect cell production of bioactive porcine FSH

The in vitro and in vivo bioactivity of recombinant porcine FSH (rpFSH) produced from insect cells through use of a baculovirus expression system were studied and compared with those of natural FSH preparations. Determination of in vitro bioactivity, using the rat Sertoli cell aromatase bioassay, indicated that rpFSH is as active as purified pituitary FSH. Determination of in vivo bioactivity, using the mouse uterine weight bioassay, indicated that rpFSH is as active as purified pituitary FSH. Using the mouse Leydig cell testosterone bioassay, it was demonstrated that the intrinsic LH bioactivity of rpFSH is negligible. The increases in ovarian and uterine weight, and the stimulation in follicular growth in immature hypophysectomized rats induced by rpFSH supplemented with hCG were comparable to those induced by natural FSH preparations. Furthermore, rpFSH alone in hypophysectomized mice stimulated preantral follicular growth to preovulatory stages, and the subsequent injection of hCG caused ovulation. These results demonstrate that in vitro and in vivo biological characteristics of rpFSH produced from baculovirus-insect cells are indistinguishable from those of FSH isolated from natural sources.