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 38
- Downloads 0
Analysis of pathogenic microorganisms in 64 077 cases of umbilical cord blood
Objective To investigate the detection of pathogenic microorganisms in umbilical cord blood and maternal blood from 2012 to 2021, so as to improve the collection of umbilical cord blood and guarantee the safety of umbili...
Application of intelligent information system of transfusion reactions in the supervision and management of transfusion reactions
Objective To analyze the application effect of intelligent information system of transfusion reactions(referred to as the system) in the supervision and management of transfusion reactions. Methods A retrospective analys...
Preparation and preliminary evaluation of sodium alginate/agarose/carboxymethyl chitosan spray film dressing carrying platelet rich plasma for wound repair
Objective To develop a spray-on membrane dressing for wound repair containing platelet rich plasma (PRP) sodium alginate (SA)/agarose(AG)/carboxymethyl chitosan (CMCS). Methods SA/AG/ CMCS were mixed in different proport...
Evaluation and improvement of blood station quality management system: based on external audit
Objective To identify the main unqualified items in the external audit of blood station quality management system (referred to as external audit), in order to take necessary measures to continuously improve the quality s...
In vitro quality evaluation of leucocyte-reduced pooled platelet concentrates prepared from whole blood stored at 4℃
Objective To investigate the feasibility of leucocyte-reduced pooled platelet concentrates from whole blood stored at 4℃, and provide theoretical basis for the components preparation. Methods The collected 400 mL ACD-B a...