Pilot-Scale Biosimilar Follicle Stimulating (FSH) Hormone Production
Project no. 21416 · Status: Kapanmış (Yayın bekleniyor) · 2019
Summary
<p>The increase in the market share of biotechnological drugs, which is increasing rapidly today, causes the need for economic raw materials, high production costs, and the need for qualified personnel.</p><p> </p><p> Follicle stimulating hormone (FSH) is one of the gonadotropic hormones (the other is LH). Both are released into the bloodstream by the pituitary gland. Follicle stimulating hormone is one of the hormones necessary for pubertal development and the development and function of the ovaries in women and testicles in men. In women, before ovulation, this hormone stimulates one of the follicles in the ovary to allow an egg to grow. It also increases the production of estradiol.</p><p> </p><p>The worldwide market for FSH is expected to reach a Compound Annual Growth Rate (CAGR) of approximately 3.7% over the next five years. According to a new study, in 2024, it will reach 1550 million US dollars from 1250 million US dollars in 2019.</p><p> </p><p>Within the scope of the presented project, recCHO cell that produces FSH with gene cloning technology from the CHOK1 cell line obtained from ATCC remained. After subcloning, the highest FSH producing cell clone was adapted to SFM medium in suspended culture and produced in the laboratory in a bioreactor system. Then, separation and purification processes were carried out by applying chromatography methods. Final recFSH was confirmed by ELISA, SDS-PAGE, and Westen Blot.</p>