Quality control methods for recombinant human endostatin / 药学学报

ABSTRACT

<p><b>AIM</b>To establish the quality control methods for recombinant human endostatin.</p><p><b>METHODS</b>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).</p><p><b>RESULTS</b>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%.</p><p><b>CONCLUSION</b>The established methods can effectively control the quality of recombinant human endostatin.</p>