Application of gel adsorption tank in large-scale production of human prothrombin complex
10.13303/j.cjbt.issn.1004-549x.2021.12.028
- VernacularTitle:凝胶吸附罐在人凝血酶原复合物规模化生产中的应用研究
- Author:
Xiao LIU
1
;
Xiangdong HAN
1
;
Yijie LI
1
;
Xingpeng WEI
1
;
Guizhen CHEN
1
;
Chenyao LEI
1
;
Anshan ZHANG
1
;
Xiaoyu LIU
1
Author Information
1. Lanzhou Lansheng Plasma-derived Biotherapies Co., Ltd. Lanzhou 730046, China
- Publication Type:Journal Article
- Keywords:
gel adsorption tank;
human prothrombin complex concentrate;
application in production
- From:
Chinese Journal of Blood Transfusion
2021;34(12):1382-1384
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To study the application effect of gel adsorbent tank in the production of human prothrombin complex concentrate(PCC). 【Methods】 Six batches of PCC were produced from 1000 L cryoprecipitated plasma, using the same gel twice for adsorption within the tank.The number of gel repeated application was examined by retrospective confirmation, and the adsorption rate, specific activity and residue of finished virus inactivation reagent were determined before and after adsorption. 【Results】 All 6 batches of PPC, produced by the same gel, satisfied quality criteria. Both PPC solution and the gel presented good color. The average activities of coagulation Factors Ⅱ, Ⅶ, Ⅸ and Ⅹ of six batches of PCC were 118.2%, 157.0%, 140.5% and 176.8%, respectively. The The adsorption capacity of coagulation factor Ⅱ, Ⅸ and Ⅹ were both 100% in the first and second adsorption, while coagulation factor Ⅶ were 75% and 81%, respectively. The average specific activity of coagulation factor Ⅸ was 0.7 IU/mg. The average residues of polysorbate 80 and tributyl phosphate products were 0 μg/mL and 33 μg/mL, respectively. The same batch of gel can be repeatedly used up to 6 times during the PCC process. 【Conclusion】 The gel adsorption tank presents good application value in the production of PCC, which can realize process amplification and automatic control.
