QUALITY CONTROL METHODS FOR RECOMBINANT HUMAN ENDOSTATIN

AIMTo establish the quality control methods for recombinant human endostatin. METHODS Biological activity was determined by endothelial cell migration assays. Peptide mapping was tested by trypsin digestion and RP-HPLC. Purity was determined by non-redued SDS-PAGE and RP-HPLC. Other tests including molecular weight, isoelectrical point, etc. were done according to the National Requirements for Biological Products (2000). RESULTS The method of bioassay was established and used for determining activity of endostatin. Specific activity of the three batchs of drug substance was 1.45×106, 1.57×106 and 2.73×106 u·mg^-1 proteins. Peptide mappings of the three batches of drug substance were completely identified. Both purity results of the products tested by SDS-PAGE and RP-HPLC were more than 99%. CONCLUSIONThe established methods can effectively control the quality of recombinant human endostatin.