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Expression of long-acting human follicle-stimulating hormone analog from Chinese hamster ovary cells and functional characterization

Xiaoping Huang, Chunxue Yang, Dongfang Jia, Xiao Wang, Junsheng Lin, Yong Diao

Follicle-stimulating hormone (FSH) is the pituitary hormone responsible for testicular tubal development and ovarian follicular recruitment and maturation. Both recombinant and purified urinary FSH are currently used for ovulation induction in women undergoing assisted reproduction. In this report, we describe Chinese hamster ovary (CHO-K1) cell expression of a novel long-acting human FSH single chain analog consisting of the native á and â subunit. A simple but readily scalable column chromatography method was developed to highly purify the recombinant FSH analog. In-vivo bioactivity was evaluated by the ovarian and uterine histopathology examinations. Single SC injection of the recombinant FSH analog (62.5 ìg/kg) induced an equivalent increase the number of antral follicle, compared with commercial FSH preparation Folltropin-V (0.5 g/ kg, twice daily for 4 days). The histopathology examination of the ovary and uterus confirmed the efficacy of the FSH analog. These findings indicate that this recombinant FSH analog could serve as a long-acting FSH preparation.