Therapeutic Products
Verification of viral inactivation/removal process for human antithrombin Ⅲ
Fu Yanli, Kong Tao, Guo Yuting, Cao Yang, Liang Lingyu
Published 2022-06-10
Cite as Int J Biologicals, 2022, 45(3): 136-139. DOI: 10.3760/cma.j.cn311962-20211019-00066
Abstract
ObjectiveTo verify and evaluate the feasibility of the solvent/detergent (S/D) method combined with nanomembrane filtration method in the preparation of human plasma antithrombin Ⅲ (AT-Ⅲ) to inactivate/remove the virus.
MethodsS/D method was used as the AT-Ⅲ virus inactivation process in human plasma, and the nanomembrane filtration method (20 nm pore size) was used as the virus removal process. The effect of virus inactivation/removal process on AT-Ⅲ activity was analyzed. Pseudorabies virus, Sindbis virus, porcine parvovirus and encephalomyocarditis virus were used as indicate viruses to verify the virus inactivation/removal effect of the above process.
ResultsThe method of S/D combined with nanomembrane filtration effectively inactivated/removed lipid-enveloped as well as non-lipid-enveloped viruses, with all indicate viruses titers decreases >4 lg. The biological activity of AT-Ⅲ and other indicators did not change significantly, with activity changes <10%.
ConclusionS/D combined with nanomembrane filtration method established in this study can effectively inactivate/remove viruses in AT-Ⅲ, providing a reference for the virus inactivation of the coagulation factor products.
Key words:
Antithrombin-Ⅲ; Virus inactivation/removal; Solvent/detergent treatment method; Nanofiltration method
Contributor Information
Fu Yanli
The Fourth Research Laboratory, Lanzhou Institute of Biological Products Co., Ltd., Vaccine Engineering Technology Center of Gansu, Lanzhou 730046, China
Kong Tao
The Fourth Research Laboratory, Lanzhou Institute of Biological Products Co., Ltd., Vaccine Engineering Technology Center of Gansu, Lanzhou 730046, China
Guo Yuting
The Fourth Research Laboratory, Lanzhou Institute of Biological Products Co., Ltd., Vaccine Engineering Technology Center of Gansu, Lanzhou 730046, China
Cao Yang
The Fourth Research Laboratory, Lanzhou Institute of Biological Products Co., Ltd., Vaccine Engineering Technology Center of Gansu, Lanzhou 730046, China
Liang Lingyu
The Fourth Research Laboratory, Lanzhou Institute of Biological Products Co., Ltd., Vaccine Engineering Technology Center of Gansu, Lanzhou 730046, China