Bassett R, De Bellis C, Chiacchiarini L, Mendola D, Micangeli E, Minari K, Grimaldi L, Mancinelli M, Mastrangeli R, Bucci R
Serono International SA, Geneva, Switzerland.
Curr Med Res Opin. 2005 Dec;21(12):1969-76. doi: 10.1185/030079905X75005.
A commercial preparation of recombinant human chorionic gonadotrophin (r-hCG, Ovitrelle) was launched in 2001. Generally, hCG is available in two formats: human chorionic gonadotrophin (u-hCG), derived from the urine of pregnant females, and r-hCG produced by DNA based biotechnology.
The analytical characteristics of a highly purified u-hCG (Gonasi HP) were assessed and compared, for the first time, with the recombinant derived r-hCG (Ovitrelle). Gonasi HP is produced by extracting and purifying hCG from urine to obtain a specific bioactivity of 5000 IU/mg protein. Ovitrelle is produced via a recombinant derived mammalian cell line and purified to obtain a specific activity of 26 000 IU/mg.
It has been documented that commercially available u-hCG preparations can contain a number of urine derived protein contaminants as well as hCG related metabolites. This is also the case for Gonasi HP, where hCG related molecules and other proteins were found to be present, including epidermal growth factor (EGF) and eosinophil derived neurotoxin (EDN). It was also demonstrated that this preparation contained high levels of oxidised hCG. r-hCG was confirmed to be essentially intact hCG, free from contaminant proteins and with very low levels of oxidised hCG.
重组人绒毛膜促性腺激素（r-hCG，Ovitrelle）的商业化制剂于2001年推出。一般来说，hCG有两种形式：从怀孕女性尿液中提取的人绒毛膜促性腺激素（u-hCG），以及通过基于DNA的生物技术生产的r-hCG。
首次评估并比较了高度纯化的u-hCG（Gonasi HP）与重组来源的r-hCG（Ovitrelle）的分析特性。Gonasi HP是通过从尿液中提取和纯化hCG来生产的，以获得5000 IU/mg蛋白质的特定生物活性。Ovitrelle是通过重组衍生的哺乳动物细胞系生产的，并经过纯化以获得26000 IU/mg的比活性。
有文献记载，市售的u-hCG制剂可能含有多种尿液来源的蛋白质污染物以及hCG相关代谢物。Gonasi HP也是如此，其中发现存在hCG相关分子和其他蛋白质，包括表皮生长因子（EGF）和嗜酸性粒细胞衍生神经毒素（EDN）。还证明该制剂含有高水平的氧化型hCG。r-hCG被证实基本上是完整的hCG，不含污染蛋白，且氧化型hCG水平非常低。
