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A process for obtaining hmg-up and non pollutant components

机译:一种获得高浓度和无污染成分的方法

摘要

This application relates to a purification method of (Human menopausal gonadotropin (HMG) for multimodal Chromatography to obtain a Composition of HMG - up (Human menopausal gonadotropin with degree of ultrapureza).Claim 1: a process for obtaining composition (Human menopausal gonadotropin (HMG - up with degree of ultrapureza) free of contaminants such as non gonadotropin plasma serine protease inhibitor, afamina, Binding Protein with insulin-like growth factor 7, - 2 glycoprotein of zinc and AlbuminWhere a Composition of gonadotropin is subjected to the following steps: (i) purification of pollutants gonadotropin using a strong anion Exchanger with multimodal functionality.Eluting buffer with a pH at a constant but changing the conductivity to obtain a fraction J3 - up only LH bioactivity; (ii) obtaining a fraction of HMG - up on stage by a Balanced mixture of bioactivities equivalent FSH from the fraction J2 With LH of the J3 fraction up obtained; (iii) subjecting The fraction of HMG - up Stages: 1) sterile Filtration, Nanofiltration, 2) and 3) precipitation; to obtain a Composition of HMG - up (Human menopausal gonadotropin with degree of ultrapureza) free of contaminants such as non gonadotropin protease inhibitor, afamina, Binding Protein with growth factor Insulin, type 7, - 2 - glycoprotein of zinc and Albumin.
机译:本申请涉及一种用于多峰色谱的(人类更年期促性腺激素(HMG)的纯化方法以获得HMG-up(具有超纯度的人类更年期促性腺激素)的组合物。权利要求1:一种获得成分(人类更年期促性腺激素(HMG)的方法-达到超纯度的程度)不含污染物,例如非促性腺激素血浆丝氨酸蛋白酶抑制剂,famina,具有胰岛素样生长因子7的结合蛋白--2种锌糖蛋白和白蛋白,其中促性腺激素的组成要进行以下步骤:( i)使用具有多峰功能的强阴离子交换剂纯化污染物促性腺激素。在恒定的pH条件下洗脱缓冲液,但改变电导率以获得部分J3-仅提高LH生物活性;(ii)获得部分HMG-逐步提高通过从J2级分中得到的生物活性当量FSH的平衡混合物与J3级分中的LH一起获得;(iii)使HMG级分-升级阶段:1)无菌过滤,纳滤,2)和3)沉淀;获得不含污染物例如非促性腺激素蛋白酶抑制剂,famina,具有生长因子胰岛素的结合蛋白,7型-2-锌糖蛋白和白蛋白的HMG-up(人类绝经的促性腺激素,具有超纯净度)组成。

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