Continued improvements in the quality and consistency of follitropin alfa, recombinant human FSH.
The use of gonadotrophins for the treatment of infertility began in the 1930s following early work on the pituitary-ovarian axis and the discovery of FSH and LH. The technological development of pharmaceutical gonadotrophins over the last 40 years has shown improvements in specific activity, purity, degradation and impurities. Throughout these pharmaceutical developments the gonadotrophin content of both urinary and recombinant preparations has been assessed using an animal in-vivo bioassay. This paper reflects upon the manufacturing history of recombinant human FSH (r-hFSH) and follitropin alfa filled by mass (FbM), and evaluates the impact of introducing a pharmaceutical product that is formulated and assayed by a physicochemical method for r-hFSH protein content. It also compares the analytical consistency of follitropin alfa FbM with another commercially available r-hFSH, follitropin beta.
Bassett
R M
RM
Global Product Development Unit, Serono International SA, Geneva, Switzerland. robert.bassett@serono.com
Driebergen
R
R
D001681:Biological Assay; D002851:Chromatography, High Pressure Liquid; D004591:Electrophoresis, Polyacrylamide Gel; D005260:Female; D005640:Follicle Stimulating Hormone / Q000032:analysis* / Q000266:history / Q000627:therapeutic use; D037201:Follicle Stimulating Hormone, beta Subunit / Q000032:analysis; D015292:Glycoprotein Hormones, alpha Subunit / Q000032:analysis* / Q000266:history / Q000627:therapeutic use; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D007247:Infertility, Female / Q000188:drug therapy*; D011134:Polysaccharides / Q000378:metabolism; D020033:Protein Isoforms / Q000032:analysis; D011786:Quality Control
D037201:Follicle Stimulating Hormone, beta Subunit; D015292:Glycoprotein Hormones, alpha Subunit; D011134:Polysaccharides; D020033:Protein Isoforms; D005640:Follicle Stimulating Hormone