摘要
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 develop the method and standard for quality control of recombinant human B lymphocyte stimulator receptor-antibody fusion protein TACI-Fc.Methods TACI-Fc was determined for biological activity by receptor binding assay using B lymphocyte stimulator as binding ligand,for protein content by RP-HPLC,and for residual CHO cell protein and protein A contents by ELISA,then digested with trypsin and subjected to peptide mapping.Other control tests were performed according to the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition）.Results Control tests were performed on bulk and final product of recombinant human TACI-Fc by the developed method,and the result showed that all the indexes met the requirements in Guideline for Quality Control of Recombinant DNA Products for Human Use and Chinese Pharmacopoeia（Volume Ⅲ,2010 edition）.Conclusion The developed method and standard may assure the safety,effectiveness and controllability of TACI-Fc,which may be used for the routine quality control of products of the same kind.
出处
《中国生物制品学杂志》
CAS
CSCD
2012年第3期329-332,共4页
Chinese Journal of Biologicals
