山东泰邦生物制品有限公司

[Objective] To evaluate the efficacy of ultraviolet-C (UVC) irradiation in inactivating porcine parvovirus (PPV), encephalomyocarditis virus (EMCV), pseudorabies virus (PRV) and vesicular stomatitis virus (VSV) within von Willebrand factor (vWF) preparations. [Methods] An ultraviolet inactivator (254 nm primary wavelength) was employed to optimize UV exposure dosages for the samples, and the initial test groups were set at five irradiation gradients: 100, 200, 400, 1 000, and 1 500 J/m2 gradients. Based on the results of the preliminary experiments, subsequent formal experiments implemented refined dosage parameters at 100, 125, 150, 175, and 200 J/m2. Virucidal efficacy against various pathogenic strains was evaluated via cytopathic effect (CPE) observation methodology, while simultaneously quantifying von Willebrand factor antigen levels (vWF∶Ag) and collagen-binding activity (vWF∶CBA) using enzyme-linked immunosorbent assays (ELISA) and automated coagulation analysis systems before and after UVC treatment. [Results] The results showed that > 100 J/m2 UVC irradiation achieved a≥4.0 log reduction factor in vWF. For vWF antigen, retention rates were observed to be 93.67%, 91.72%, 93.54%, 79.05%, and 85.50% at UVC doses of 100, 125, 150, 175, and 200 J/m2, respectively. Similarly, the retention rates of vWF collagen-binding activity were 81.11%, 87.81%, 86.15%, 73.73%, and 73.72% under the same dose conditions. [Conclusion] Considering both inactivation efficacy and functional preservation while ensuring safety and effectiveness, 100-150 J/m2 represents the optimal inactivation dose.

It is necessary to improve the stability of human serum albumin in response to the complex temperature, light and other conditions during the manufacture and storage. In this paper, the stabilization effect and simple stabilization mechanism of ligands on albumin were described from the perspective of ligand binding to albumin.Through review and comparison, it can be concluded that the common ligand sodium octanoate mainly plays a role in improving thermal stability, and the common ligand N-acetyl-L-tryptophan mainly plays a role in improving antioxidant activity, N-acetyl-L-methionine has better antioxidant and anti-photooxidation than N-acetyl-L-tryptophan.

Objective To explore the factors that affect the coordinated development of blood banks and apheresis plas-ma collection banks(hereinafter referred to as plasma banks),and explore feasible measures for the coordinated develop-ment of blood banks and plasma banks.Methods The blood information management system and blood source information management system were used to retrieve related data of blood and plasma donation from 9 cities in Shandong province from 2017 to 2021.The number of blood donors and plasma donors and the intersection of them were analyzed.The data analysis was performed using chi-square test,and a questionnaire survey was conducted to investigate the policies and information status,as well as expectations for coordinated development for blood and plasma donation.Results From 2017 to 2021,the total number of blood donors in 9 cities was higher than that of plasma donors,both have been increasing year by year,and the increase in plasma donors was significantly higher than that of blood donors(131.78%vs 23.90%,P<0.05).The inter-section proportion of blood and plasma donors had increased from 0.45%in 2017 to 1.04%in 2021,with an increase of 131.11%.Among the administrative regions where the participating blood and plasma banks located,94.2%have not re-leased relevant policy to promote the coordinated development of blood and plasma donation.The majority(63%)expected blood banks and plasma banks to be set at a distance more than 50 km apart.The top four functional requirements for the in-terconnection between blood banks and plasma banks management information system were blood test results(94.61%),ID number(87.54%),blood and plasma donation records(85.51%)and health consultation/examination results(82.15%).The top four elements of coordinated development between blood and plasma banks were policy support(96.25%),informa-tion networking(92.36%),top-level design(87.44%)and cultural construction(86.58%).Conclusion The number of donors who donate both blood(mainly whole blood)and plasma has been increasing year by year,which deserves our close attention.To achieve the coordinated development of blood donation and plasma donation,policy support is the most crucial and fundamental means.Establishment of a standard system and the share of blood and plasma donation information is neces-sary for blood informatization construction.It was critical to promote the coordinated development of blood and plasma dona-tion and ensure blood safety with improving legislation,formulating policies for coordinated development,strengthening top-level design,standardizing the publicity of blood and plasma donation and establishing the idea that blood and plasma dona-tion are equally honorable.

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.