Quality control methods for recombinant human endostatin
Li, Y.-H.; Wang, J.-z.; Han, C.-m.; Zhang, Y.; Rao, C.-m.
Yao Xue Xue Bao 37(10): 807-811
2002
ISSN/ISBN: 0513-4870 PMID: 12567867 Document Number: 542533
To establish the quality control methods for recombinant human endostatin. Biological activity was determined by endothelial cell migration assays. Peptide mapping was tested by trypsin digestion and RP-HPLC. Purity was determined by non-reduced SDS-PAGE and RP-HPLC. Other tests including molecular weight, isoelectrical point, etc. were done according to the National Requirements for Biological Products (2000). 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 x 10(6), 1.57 x 10(6) and 2.73 x 10(6) 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%. The established methods can effectively control the quality of recombinant human endostatin.