Optimization of large-scale production process for human prothrombin complex concentrates
10.13303/j.cjbt.issn.1004-549x.2023.12.015
- VernacularTitle:高收率人凝血酶原复合物生产工艺优化
- Author:
Liangchao ZHAO
1
;
Guanjun LI
1
;
Xiaowei MA
1
;
Dongsheng ZHAO
1
;
Minghua WNAG
1
;
Bo SONG
1
Author Information
1. Hualan Biotechnology Co. Ltd, Xinxiang 453003, China
- Publication Type:Journal Article
- Keywords:
prothrombin complex concentrates;
human plasma;
cryoprecipitate supernatant;
purification/blood products
- From:
Chinese Journal of Blood Transfusion
2023;36(12):1143-1147
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To determine the optimal process conditions for efficiently extracting human prothrombin complex concentrates from human plasma. 【Methods】 Using human plasma as the materials and the yield of prothrombin complex concentrates as the evaluation standard, the preparation process parameters were studied and optimized through design of exporement(DOE), orthogonal experiments, and single factor experiments. 【Results】 The optimal process conditions were as follows: DEAE Sephadex A50 gel was selected, which balanced to pH 7.6, and then the amount of 1.7-2.5 g/L of plasma weight is added into the cryoprecipitate supernatant for adsorption for 40 minutes; Washing solution (0.15-0.175 mol/L sodium chloride) with 3 times the volume of gel was washed 3 times, and eluent (0.5-2.0 mol/L sodium chloride) was washed 3 to 5 times; Add stabilizer (heparin 35 IU, sodium chloride 0.1 mol/L) for ultrafiltration dialysis. 【Conclusion】 By using the optimized process mentioned above, the yield(measured by human coagulation factor IX)can reach 620 000 to 630 000 IU/ton of plasma, which is suitable for large-scale production.
