Evaluation of Recombinant Human Interleukin-15 Reference Standard
GUO Ying, TAO Lei, HAN Chun-mei, YANG Jing-qing, QIN Xi, RAO Chun-ming*
National Institute for Food and Drug Control, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing 100050, China
Abstract��OBJECTIVE To evaluate the reference standard of recombinant human interleukin-15 (IL-15) for the effective quality control of IL-15 products according to the requirements of Chinese Pharmacopeia.METHODS The biological activity, concentration, purity, and isoelectric point of IL-15 were tested according to Chinese Pharmacopeia (volume ��, 2010 edition). The primary structure was confirmed by analyzing the N-terminal amino acid sequence and relative molecular mass and peptide mass mapping. RESULTS The measured biological activity of IL-15 was 1.03��107 IU��mg-1, the content was (0.879��0.065) mg��mL-1, the purities tested by SDS-PAGE and SEC-HPLC were all 100%, and the isoelectric point was 5.2, which all met the criteria specified in the quality standard. The observed relative molecular mass, 12 900.80, was consistent with theoretical value (12 900.71). Its amino acid sequence was verified with coverage of 100%. The disulfide bonds were identified to to be Cys36-Cys86/Cys43-Cys89, which was in accordance with the published papers. CONCLUSION This reference standard, which is qualified and has correct amino acid sequence, can be used for the routine quality control of IL-15.
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2016, Vol. 51 
