FSH Human
Description
FSH Human Recombinant produced in HEK-293 cells is heterodimeric, glycosylated, polypeptide chain transfected with two expression plasmids encoding the human FSH-alpha chain (Accession # P01215) (Ala25-Ser116) and human FSH-beta chain (Asn19-Glu129) (Accession # P01225) having an approximate Mw of 25 kDa.
FSH human recombinant is purified by proprietary chromatographic techniques.
Product Specs
Recombinant human FSH is a lab-made version of the hormone. It is produced in HEK-293 cells, a type of human cell line commonly used in biological research. This FSH product is a heterodimer, meaning it consists of two different protein chains (alpha and beta). It is also glycosylated, meaning it has sugar molecules attached to it. These modifications are important for the hormone's stability and function. The molecular weight of this recombinant FSH is approximately 25 kDa. The purification process utilizes specialized chromatographic techniques to ensure high purity.
The FSH powder is freeze-dried from a solution containing PBS with a pH of 7.4. The solution is filtered through a 0.2 µm filter before freeze-drying.
To reconstitute the freeze-dried FSH, it is recommended to dissolve it in sterile 18 megaohm-centimeter (MΩ·cm) H2O to a concentration of at least 100 µg/ml. Once reconstituted, the FSH solution can be further diluted in other aqueous solutions as needed.
The biological activity of this FSH product is determined by its ability to stimulate cAMP production in Chinese Hamster Ovary (CHO) cells that have been specially modified to express the human FSH receptor. The ED50, which represents the effective dose required to achieve 50% of the maximum response, is in the range of 80-450 pg/ml.
FSH subunit alpha: APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLR SKKTMLVQKNVTSESTCCVAKSYNRVTVMGGFKVENHTACHCSTCYYHKS.
FSH subunit beta: NSCELTNITIAIEKEECRFCISINTTWCAGYCYTRDLVYKDP ARPKIQKTCTFKELVYETVRVPGCAHHADSLYTYPVATQCHCGKCDSDSTDCTVRGLGPSYCSFGEMKE.
Product Science Overview
Follicle Stimulating Hormone (FSH) is a critical hormone in the regulation of reproductive processes in both men and women. It is produced by the anterior pituitary gland and plays a key role in the maturation of ovarian follicles in women and spermatogenesis in men . The development of recombinant DNA technology has allowed for the production of human recombinant FSH (rFSH), which has become a cornerstone in the treatment of infertility.
Recombinant FSH is produced using Chinese hamster ovary (CHO) cells that have been transfected with the genes encoding the two subunits of human FSH . This method ensures a high purity product, devoid of luteinizing hormone (LH) activity, and very similar to natural FSH . The recombinant form of FSH includes follitropin alfa, beta, and delta, which are used in various clinical applications .
Recombinant FSH is primarily used in assisted reproductive technology (ART) to stimulate follicular growth. It is administered to women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intrauterine insemination (IUI) . The hormone helps in the development of multiple follicles, increasing the chances of retrieving multiple oocytes for fertilization .
Clinical studies have shown that recombinant FSH is effective in inducing ovulation and achieving pregnancy in women with anovulatory cycles . It has also been found to be safe, with a similar side effect profile to that of urinary-derived FSH . The introduction of biosimilars of recombinant FSH has further expanded the options available for patients, offering similar efficacy and safety at a potentially lower cost .
