Bassett R M, Driebergen R
Global Product Development Unit, Serono International SA, Geneva, Switzerland.
Reprod Biomed Online. 2005 Feb;10(2):169-77. doi: 10.1016/s1472-6483(10)60937-6.
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.
20世纪30年代，随着对垂体-卵巢轴的早期研究以及促卵泡生成素（FSH）和促黄体生成素（LH）的发现，促性腺激素开始用于治疗不孕症。在过去40年中，药物促性腺激素的技术发展在比活性、纯度、降解和杂质方面都有了改进。在这些药物研发过程中，尿源性和重组制剂中的促性腺激素含量一直通过动物体内生物测定法进行评估。本文回顾了重组人促卵泡生成素（r-hFSH）和按质量填充的重组促卵泡素α（FbM）的生产历史，并评估了引入一种通过物理化学方法测定r-hFSH蛋白含量的制剂和检测的药品所产生的影响。文章还比较了重组促卵泡素α FbM与另一种市售r-hFSH——重组促卵泡素β的分析一致性。
