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  

Application of gel adsorption tank in large-scale production of human prothrombin complex

作　　者：刘晓 韩祥东 李毅杰 魏兴鹏 陈桂珍 雷晨瑶 张安山 刘晓宇 LIU Xiao;HAN Xiangdong;LI Yijie;WEI Xingpeng;CHEN Guizhen;LEI Chenyao;ZHANG Anshan;LIU Xiaoyu(Lanzhou Lansheng Plasma-derived Biotherapies Co.,Ltd,Lanzhou 730046,China)

机构地区：[1]兰州兰生血液制品有限公司,甘肃兰州730046

出　　处：《中国输血杂志》2021年第12期1382-1384,共3页Chinese Journal of Blood Transfusion

摘　　要：目的研究凝胶吸附罐在PCC生产中的应用效果。方法在1 000 L去冷沉淀血浆规模上使用同一批凝胶生产6批,PCC生产工艺中2次凝胶吸附均在吸附罐中进行。通过回顾性确认方式考察凝胶使用次数,同时考察吸附前后凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ活性的吸附率、比活性、成品病毒灭活试剂残留情况。结果同批凝胶使用6次生产的PCC成品质量指标均合格,PCC原液外观颜色保持一致,凝胶外观颜色较好。6批PCC成品中凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ活性平均值分别为118.2%、157.0%、140.5%、176.8%。第1、2次吸附的凝血因子Ⅱ、Ⅸ、Ⅹ活性吸附率平均值为100%,2次吸附凝血因子Ⅶ吸附率平均值分别为75%和81%。PCC成品中凝血因子Ⅸ比活性平均值为0.7 IU/mg。PCC成品中磷酸三丁酯和聚山梨酯80残留量平均值分别为0μg/mL和33μg/mL。同批凝胶在PCC生产过程中可以使用6次。结论凝胶吸附罐在PCC生产中具有良好的应用价值,能够实现工艺放大和自动化控制。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.

关 键 词：凝胶吸附罐 人凝血酶原复合物 生产应用 

分 类 号：R977.8[医药卫生—药品]