Selection of sterilizing-grade filter for preparation of human coagulation factor Ⅷ/ von Willebrand factor complex
Journal Title: Chinese Journal of Blood Transfusion - Year 2023, Vol 36, Issue 6
Abstract
Objective To screen the sterilizing-grade filters applicable for production of human coagulation factor Ⅷ/von Willebrand factor complex(FⅧ/VWF)and study the sterilization filtration process. Methods Four sterilizing-grade filters for FⅧ/VWF were evaluated through indicators such as filtration capacity, filtration flux, recovery rate of FⅧ activity, recovery rate of VWF activity, recovery rate of VWF antigen, recovery rate of protein and VWF molecular distribution. The sterilizing-grade filter with the best filtration performance was selected for further study. The study was designed by general full-factor design to determine the appropriate filitered protein concentration and filitered speed range through evaluating the total filtered protein amount, recovery rate of protein and filtration efficiency, and then the process operation parameters was determined. Results The filtration flux of Sartobran P, Sartopore 2 XLG, Sartopore Platinum and Sartopore 2 XLI were 1.71±0.01, 1.80±0.01, 1.34±0.01, and 1.81±0.04 L·(m2)-1·min-1, respectively; the recovery rates (%) of FⅧ activity were 97.09±2.82, 99.22±0.99, 96.87±1.85 and 93.76±1.21, respectively; the recovery rates (%) of VWF activity were 98.12±1.42, 99.95±1.85, 94.80±1.62 and 92.09±1.67, respectively. Between Sartopore 2 XLG and Sartobran P, the difference of filtration flux (P<0.001) was statistically significant; between Sartopore 2 XLG and Sartopore Platinum, the differences of the filtration flux (P<0.001) and VWF potency recovery rate (P<0.05) were statistically significant; between Sartopore 2 XLG and Sartopore 2 XLI, the differences of FⅧ potency recovery rate (P<0.01) and VWF potency recovery rate (P<0.01) were statistically significant. The optimal process operating space of Sartopore 2 XLG was protein concentration of 0.45-0.58 mg/mL, and filtration rate of 1.48-2.95 L·(m2)-1·min-1. Conclusion Sartopore 2 XLG is the most suitable filter for the production of FⅧ/VWF and the DoE test proves that it has good process operation space.
Authors and Affiliations
Quanjuan GUO, An ZHOU, Wenjie LIU, Yike XU, Wenqiang SHI, Chen CHEN, Changyong JIAN
Keywords
Related Articles
- EP ID EP738563
- DOI 10.13303/j.cjbt.issn.1004-549x.2023.06.006
- Views 28
- Downloads 0
Application of inspection sheet in apheresis platelet collection
Objective To explore the effect of inspection sheet on improving the quality of apheresis platelet, the satisfaction of blood donors and the cooperation ability of phlebotomists in the process of apheresis platelet colle...
The introduction to and inspiration from haematological management of major haemorrhage: a British Society for Haematology guideline
Evidenced based and practical guidelines have important role in the decrease of mobility and mortality of the patients with major haemorrhage. Recently, British Society for Haematology updated a guideline on haematologic...
Drug resistance mutation analysis of HIV-1 among blood donors in Dalian: 2011—2020
Objective To study the distribution and trend of HIV-1 drug resistance mutation in Dalian blood donors between 2011 and 2020. Methods The protease-reverse transcriptase (PR-RT) region was sequenced in Dalian blood donors...
Analysis of perioperative blood transfusion and the influencing factors of mass-transfusion in patients underwent heart transplantation
Objective To provide references for clinical prediction of blood preparation and blood consumption, as well as the influencing factors of mass-transfusion by analyzing the perioperative blood transfusion in patients unde...
A multicenter phase Ⅲ clinical study of human prothrombin complex concentrate in treatment of hemophilia B
Objective To evaluate the clinical efficacy and safety of one kind of human prothrombin complex concentrate in treatment of patients with hemophilia B. Methods The clinical data of 36 patients with hemophilia B treated w...