Production of Recombinant Follicle Stimulating Hormone (1545 words)

Assume you are employed in a start-up bio-pharma company and you are tasked with establishing the procedures and processes for producing follicle stimulating hormone (FSH) as a biotherapeutic for human use.
Present the plan of what you would do to achieve this.

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Follicle stimulating hormone is one of the gonadotrophins produced and secreted by the anterior lobe of the pituitary gland. They are involved in the regulation of gonadal function. In males, FSH helps control spermatogenesis, while in females it regulates follicle growth. Moreover, FSH works with LH and oestrogen to stimulate proliferation of granulosa cells, leading to follicular growth (Crommelin et al., 2013). Deficiency in this hormone can cause infertility; this condition is called anovulation and can be treated by using gonadotropins to achieve mono-follicular development (Crommelin et al., 2013). Previously, follicle stimulating hormone (FSH) preparations for infertility treatment were derived from the urine of postmenopausal women (Group, 1998). Being a natural source, availability is limited, the product quality will vary and there is the chance of contamination with luteinising hormone (LH)(Olijve et al., 1996, Crommelin et al., 2013). However, the advances in recombinant DNA technology significantly improved the production of FSH preparation with enhanced purity and availability (Group, 1998).Recombinant FSH (r-hFSH) is produced by cloning the genes that encode the α- and ß-subunits of human FSH then transferring them into Chinese hamster ovary (CHO) cells (Olijve et al., 1996). In this paper, we will discuss the biotechnology involved in the process of producing recombinant follicle stimulating hormone from a recombinant cell line producing r-hFSH via its characterization and the analysis of the final product.
Structure of Follicle stimulating hormone:
FSH is a heterodimeric glycoprotein consisting of two non-covalently...