[Quality control methods for recombinant human endostatin].
OBJECTIVE
To 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-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).


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 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%.


CONCLUSIONS
The established methods can effectively control the quality of recombinant human endostatin.
Li
Yong-Hong
YH
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Wang
Jun-zhi
JZ
Han
Chun-mei
CM
Zhang
Yi
Y
Rao
Chun-ming
CM
D002465:Cell Movement / Q000187:drug effects*; D002478:Cells, Cultured; D043169:Endostatins / Q000494:pharmacology*; D004730:Endothelium, Vascular / Q000166:cytology; D006801:Humans; D011786:Quality Control; D011994:Recombinant Proteins / Q000494:pharmacology; D013678:Technology, Pharmaceutical / Q000379:methods*
D043169:Endostatins; D011994:Recombinant Proteins