My Cart [ 0 ]
Home > Cell Biology > Stable Cell Lines > GONAL F Biosimilar Stable Cell Line

GONAL F Biosimilar Stable Cell Line

Follitropin Alfa, Recombinant Human Follicle Stimulating Hormone, FSH

Catalog No. Product Name Size List Price (US$) Quantity
C014 GONAL F Biosimilar Stable Cell Line 1 package Request

GONAL-F, recombinant human FSH, is used for infertility therapy, mainly for ovarian hyperstimulation as part of IVF. Follicle-stimulating hormone (FSH), synthesized and secreted by gonadotrophs of the anterior pituitary gland, regulates the development, growth, pubertal maturation, and reproductive processes of human and other animal bodies. FSH and luteinizing hormone (LH) act synergistically in reproduction. The structure of FSH is similar to those of LH, thyroid-stimulating hormone (TSH), and human chorionic gonadotropin (hCG). The protein dimer contains 2 polypeptide units, named as alpha and beta subunits. The alpha subunits of LH, FSH, TSH, and hCG are identical, containing 92 amino acids. Their beta subunits vary. The FSH beta subunit confers its specific biologic action and is responsible for interaction with the FSH-receptor. FSH is a glycoprotein. Only if there is sugar modification on each monomeric subunit, the protein is functional. The sugar attached consists of fucose, galactose, mannose, galactosamine, glucosamine, and sialic acid, which is critical for its biologic half-life of 3–4 hours.

C014: GONAL-F Biosimilar Stable Cell Line (CHO)

The yield of GONAL-F biosimilar from the CHO stable cell line was above 100 mg/L.

The GONAL-F stable cell line alone can be transferred alone or together with the technology of process development and/or antibody purification.

Our partner in China will start to sell the recombinant FSH protein as a drug in China later 2022. The protein yield is extremely high so that the manufacturing cost is low. We are looking for a partner outside China to distribute the GONAL-F biosimilar.

We can supply you: clinical data in China, and drug substance or even drug product for clinical trial application in Europe and USA.

It means that you do not need to worry about manufacturing, and that you are just responsible for regulatory and marketing.

One of the recombinant FSH proteins that we licensed to another Chinese biopharma company has been sold as a drug in China for 1 year.

We also have the FSH-Fc protein but have terminated the FSH-Fc project after the clinical trial Phase II because of the financial issue.

Syd Labs also provides the following hormone biosimilar stable cell lines:
Luveris Biosimilar Stable Cell Line (luteinizing hormone, LH)
Thyrogen Biosimilar Stable Cell Line (thyroid-stimulating hormone, TSH)
Ovidrel Biosimilar Stable Cell Line (human chorionic gonadotropin, hCG)

Related Links

See our Privacy Policy