Development of the First Batch of National Protein Content Standard RS2 for Recombinant Human Albumin
WANG Min-li1, WANG Tao2, LI Yan3, SHAO Hong4, LI Lei5, FAN Jia-jin6,MA Li7, LI Bao-quan8, LUO Qing9, XU Miao1*, HOU Ji-feng1*
1. National Institutes for Food and Drug Control, WHO Collaboration Center for Standardization and Evaluation of Biologicals, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing 100050, China;
2. Lanzhou Institute of Biological Products Co., Ltd., Lanzhou 730046, China;
3. Sichuan Institute For Food and Drug Control, Chengdu 611731, China;
4. Shanghai Institute for Food and Drug Control, Shanghai 201203, China;
5. BioRay Pharmaceutical Co.,Ltd., Taizhou 318000, China;
6. China Biologic Products Holdings, Inc., Taian 271000, China;
7. Hualan Biological Engineering, Inc., Xingxiang 453003, China;
8. Innovent Biologics, Inc., Suzhou 215123, China;
9. Sunshine Guojian Pharmacutical(Shanghai) Co., Ltd.,Shanghai 201203, China
OBJECTIVE To develop a national standard for determination of protein content of recombinant human albumin. METHODS The recombinant human albumin product was selected as raw material, then diluted with 9 g·L-1 NaCl solution and sterilized by filtration. Collaborative calibration and stability monitoring were carried out in eight laboratories according to the confirmed and verified methods. RESULTS Eight laboratories used HPLC method, Lowry method, UV method and BCA method to determine the protein content of the national reference standard 2(RS2) for recombinant human albumin. The inter-laboratory mean value was 1961 μg·mL-1(range 1 904-2 063 μg·mL-1,95% CI 1 917-2 006 μg·mL-1). The mean standard deviation of calibration results between laboratories was 52.89, the standard error was 18.70, and the inter-laboratory relative standard deviation (RSD) was 2.70%. The stability of the standard sample at 2-8 ℃ was monitored continuously for 19 m and there was no trend of change in protein content. It is suggested that the standard would be stored and transported at 2-8 ℃. CONCLUSION The national protein content standard RS2 for recombinant human albumin meets the relevant standards, which can be used for the quality control of recombinant human albumin.
王敏力, 王弢, 李炎, 邵泓, 李镭, 范加金, 马力, 李宝泉, 罗清, 徐苗, 侯继锋. 首批重组人血白蛋白蛋白质含量RS2国家标准品的研制[J]. 中国药学杂志, 2022, 57(15): 1283-1286.
WANG Min-li, WANG Tao, LI Yan, SHAO Hong, LI Lei, FAN Jia-jin,MA Li, LI Bao-quan, LUO Qing, XU Miao, HOU Ji-feng. Development of the First Batch of National Protein Content Standard RS2 for Recombinant Human Albumin. Chinese Pharmaceutical Journal, 2022, 57(15): 1283-1286.