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目的:1.建立适用于重组人生长激素(rh-GH)生产质量控制的大肠杆菌蛋白残留(ECP)测定方法。2.完成对重组人激素H1(rh-H1)的重要质量控制项目:含量、纯度、肽图的检定。方法:采用双抗体夹心酶联免疫吸附法(ELISA)对rh-GH产品中的ECP残留进行检测,并按照中国药典、生物制品规程及ICH有关要求进行方法学验证。采用反相高效液相色谱法对rh-H1进行了含量测定、纯度检查和肽图分析。结果:1.根据研究所得真实可靠的方法学评价结果,建立并规范了可用于rh-GH常规生产工艺控制的宿主蛋白残留检测方法。2.对三批rh-H1原液检定结果分别为,含量:100.5%、101.1%、99.8%;纯度:98.0%、98.4%、97.8%;肽图:三批原液肽图均与对照品一致。表明该产品的此三项指标均符合规定。
To establish a method for the determination of E.coli residue (ECP) suitable for the quality control of recombinant human growth hormone (rh-GH). 2. Complete the recombinant human hormone H1 (rh-H1) important quality control projects: content, purity, peptide map of the test. Methods: ECP residues in rh-GH products were detected by double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) and validated by methodology according to Chinese Pharmacopoeia, biological procedures and ICH requirements. The content of rh-H1 was determined by RP-HPLC, the purity was checked and the peptide map was analyzed. According to the real and reliable methodological evaluation results obtained in the study, a method for the determination of host protein residues that can be used for routine rh-GH production process control was established and standardized. The results of three batches of rh-H1 stock solution were: 100.5%, 101.1%, 99.8%; Purity: 98.0%, 98.4%, 97.8%; Indicate that the product of these three indicators are in line with the provisions.