The in vitro and in vivo bioactivity of recombinant porcine FSH (rpFSH
) produced from insect cells through use of a baculovirus expression s
ystem were studied and compared with those of natural FSH preparations
. Determination of in vitro bioactivity, using the rat Sertoli cell ar
omatase bioassay, indicated that rpFSH is as active as purified pituit
ary FSH. Determination of in vivo bioactivity, using the mouse uterine
weight bioassay, indicated that rpFSH is as active as purified pituit
ary FSH. Using the mouse Leydig cell testosterone bioassay, it was dem
onstrated that the intrinsic LH bioactivity of rpFSH is negligible. Th
e increases in ovarian and uterine weight, and the stimulation in foll
icular growth in immature hypophysectomized rats induced by rpFSH supp
lemented with hCG were comparable to those induced by natural FSH prep
arations. Furthermore, rpFSH alone in hypophysectomized mice stimulate
d preantral follicular growth to preovulatory stages, and the subseque
nt injection of hCG caused ovulation. These results demonstrate that i
n vitro and in vivo biological characteristics of rpFSH produced from
baculovirus-insect cells are indistinguishable from those of FSH isola
ted from natural sources. (C) 1997 by Elsevier Science Inc.