In this study, the efficiency of binary ethyleneimine (BEI) in combination with formaldehyde (FA) and glutaraldehyde (GTA) in inactivating the Indian FMDV vaccine strains is compared. The acceptable safety of virus inactivation was faster and the inactivation rates were increased many-folds with combination of inactivants than BEI alone. FMDV A was inactivated rapidly than the other two serotypes with BEI + FA combination. Inactivation plots were linear for all the serotypes irrespective of inactivation process. Further, the integrity studies on 146S using serotype specific ELISA indicated no significant change in the antigenic mass of all the serotypes throughout the inactivation process. However, the loss of 146S antigen occurred in the subsequent steps of downstream processing. Further, the studies on intactness of viral RNA using real time PCR indicated the amplification of 1D gene sequences in all the preparations of timed samples irrespective of serotypes/inactivation process. Further, inactivated virus preparation (146S) was more stable at lower temperatures for all the serotypes/inactivation process. Among the combinations of inactivants, BEI + FA out performed compared to BEI + GTA and BEI in terms of inactivation rates, 146S yield and its storage stability, irrespective of the serotypes.

译文

在这项研究中,比较了二元乙烯亚胺 (BEI) 与甲醛 (FA) 和戊二醛 (GTA) 联合灭活印度FMDV疫苗株的效率。与单独使用灭活剂相比,灭活剂的可接受安全性更快,灭活率提高了许多倍。FMDV A比BEI FA组合的其他两种血清型迅速失活。与灭活过程无关,所有血清型的灭活图都是线性的。此外,使用血清型特异性ELISA对146S的完整性研究表明,在整个灭活过程中,所有血清型的抗原质量没有显著变化。然而,146S抗原的损失发生在下游处理的后续步骤中。此外,使用实时PCR对病毒RNA的完整性进行的研究表明,无论血清型/失活过程如何,在所有定时样品的制剂中都扩增了1D基因序列。此外,对于所有血清型/灭活过程,灭活病毒制剂 (146S) 在较低温度下更稳定。在灭活剂的组合中,与BEI GTA和BEI相比,BEI + FA在灭活率,146S产率及其储存稳定性方面进行了比较,而与血清型无关。

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