TY  - JOUR
AU  - FENG, Teng
AU  - QI, Fangling
AU  - WANG, Qiang
AU  - WANG, Rui
AU  - WANG, Shaowei
AU  - JIA, Junting
AU  - CHEN, Chongwei
AU  - ZHANG, Jingang
AU  - YUAN, Fang
AU  - MA, Yuyuan
PY  - 2025
TI  - Effects of freeze-drying and dry heat virus inactivation processes on the biological activities of human plasma derived α2-macroglobulin
JO  - Military Medical Sciences
SN  - 1674-9960
SP  - 35
EP  - 40
VL  - 49
IS  - 1
AB  - ObjectiveTo assess the impact of freeze-drying and dry heat virus inactivation processes on the activity of α2-macroglobulin (A2M) derived from human plasma Cohn fraction Ⅳ.MethodsA2M derived from human plasma Cohn fraction Ⅳ was prepared and subjected to programmed freeze-drying with dry heat virus inactivation. The lyophilized products were evaluated for their appearance, water content, and validation of the viral inactivation process. The bioactivity of the products before and after lyophilization as well as before and after dry heat inactivation was determined via trypsin inhibition, and the comparisons were studied.ResultsThe appearance of the lyophilized product was fluffy, and the water content was (5.83±0.45)%. The specific activities of the samples before and after lyophilization were (10.199±0.137) and (10.033±0.201) μg/mg, respectively, with no statistically significantdifference between the two groups (P> 0.05).The viral inactivation of the samples was carried out by using dry heat inactivation conditions at 100 ℃ for 30 min. After inactivation, the reduction was ≥5.125 LgTCID50/0.1 mL in Pseudorabies virus (PRV) titers, ≥4.500 LgTCID50/0.1 mL in Sindbis virus (SinV) titers ,≥6.375 LgTCID50/0.1 mL in encephalomyocarditis virus (EMCV) titers , and ≥4.500 LgTCID50/0.1 mL in porcine parvovirus (PPV) titers. The specific activities of the samples before and after dry heat were (9.921±0.292) and (10.091±0.278) μ g/mg, respectively, with no statistically significant difference between the two groups.ConclusionA2M derived from human plasma Cohn fraction Ⅳ, when subjected to freeze-drying followed by dry heat inactivation at 100 ℃ for 30 minutes, can effectively inactivate viruses without altering the biological activity of the product.
UR  - https://doi.org/10.7644/j.issn.1674-9960.2025.01.006
DO  - 10.7644/j.issn.1674-9960.2025.01.006