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目的建立重组人B淋巴细胞刺激因子受体-抗体融合蛋白(TACI-Fc)的质控方法和质量标准。方法采用以B淋巴细胞刺激因子作为配体的受体结合法测定TACI-Fc的生物学活性;反向液相色谱(RP-HPLC)法测定蛋白含量及纯度;ELISA法分别测定残留CHO细胞蛋白和蛋白A;胰蛋白酶酶切后分析肽图;其余检测项目均按《中国药典》三部(2010版)规定进行。结果用建立的方法对重组人TACI-Fc原液和成品进行检定,各项指标均符合《人用重组DNA制品质量控制技术指导原则》和《中国药典》三部(2010版)的要求。结论建立的质控方法和质量标准具有保证产品安全有效、质量可控的特点,可用于该类产品的常规检定。
Objective To establish a quality control method and quality standard for recombinant human B lymphocyte stimulating factor receptor-antibody fusion protein (TACI-Fc). Methods The biological activity of TACI-Fc was determined by the receptor binding method using B lymphocyte stimulating factor as ligand. The protein content and purity were determined by reverse-phase liquid chromatography (RP-HPLC). The content of residual CHO cell protein And protein A; tryptic digest analysis of peptide map; the remaining test items are according to “Chinese Pharmacopoeia” three (2010 edition) requirements. Results The recombinant human TACI-Fc stock solution and finished product were assayed by the established method. All the indexes were in line with the “Technical Guidelines for Quality Control of Human Recombinant DNA Products” and “Chinese Pharmacopoeia” (2010 edition). Conclusion The established quality control methods and quality standards have the characteristics of ensuring the safety and effectiveness of the products and controlling the quality of the products, and can be used for the routine verification of such products.