Viral inactivation capacity of Melagenina® Plus during the storage step

This work was aimed at validating the viral inactivation property during the storage step of the production process of Melagenina® Plus, which is a Cuban biological product for the treatment of vitiligo. The product was challenged at storage with high loads of four viral models, corresponding to three enveloped and one non-enveloped virus, two of them RNA and the other two DNA viruses: the human immunodefi ciency virus type 1 (HIV-1), the bovine viral diarrhea virus (BVDV), the porcine herpes virus type 1 (PHV-1) and the canine parvovirus (CPV). The viral titer was determined using the Reed-Muench method based on the viral cytopathic effect, and reduction factors were calculated as the difference of viral loads at the beginning and the end of the step. Enveloped viruses were inactivated between days 1 to 3, and the enveloped virus (CPV) was achieved after 21 days. The viral load showed a very highly signifi cant decrease (p < 0.0001), being conditioned to storage temperature (30 ± 5 °C) and ethanol concentration (71 % minimum). The reduction factors achieved on this step (1:5.0 log for HIV-1; 3.5 log for BVDV; 4.24 log for PHV-1 and 5.8 log for CPV) characterized the adequate level of safety of the Melagenina® Plus production process.