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Home Articles Vol 30,2026 No.7 Detail

Validation of virus inactivation/removal efficacy in production process of transfer factor solution

Published on Aug. 12, 2026Total Views: 33 times Total Downloads: 4 times Download Mobile

Author: XUE Meiling 1 GUO Weizhen 1 WANG Hongxin 1 WANG Chuanli 1 CHEN Meihong 1 WEI Xiaoliang 1

Affiliation: 1.Xi'an Jinhua Pharmaceutical Factory, Jinhua Enterprise (Group) Co., Ltd., Xi'an 710304, China

Keywords: Transfer factor solution Virus inactivation Virus removal Pasteurization Ultrafiltration membrane filtration method

DOI: 10.12173/j.issn.2097-4922.202604046

Reference: XUE Meiling,GUO Weizhen,WANG Hongxin,WANG Chuanli,CHEN Meihong,WEI Xiaoliang. Validation of virus inactivation/removal efficacy in production process of transfer factor solution[J]. Frontiers in Pharmaceutical Sciences,2026,30(7):1170-1177. DOI:10.12173/j.issn.2097-4922.202604046[Article in Chinese]

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Abstract

Objective To verify the virus inactivation/removal effect of the production process of transfer factor solution.

Methods Pseudorabies virus (PRV), vesicular stomatitis virus (VSV), encephalomyocarditis virus (EMCV) and porcine parvovirus (PPV) were selected as indicator viruses. The virus inactivation and removal efficiencies of pasteurization method (80 ℃ for 30 min) and ultrafiltration membrane filtration method (5KD ultrafiltration membrane filtration) against the four viruses were evaluated under process conditions with scaled-down production batches.

Results Three batches of samples were processed using two different virus inactivation/removal methods, the log reduction values of PRV, VSV, EMCV and PPV all exceeded 4 logs.

Conclusion The established pasteurization and the ultrafiltration membrane filtration methods can effectively remove the indicator viruses PRV, VSV, EMCV, and PPV and the related viruses they represent.

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