Gamma irradiation of human platelet lysate: validation of efficacy for pathogen reduction and assessment of impacts on hpl performance

ConclusionIn this study, we validated the efficacy of gamma irradiation for virus inactivation. Four model viruses (BVDV, Reo3, HSV1, MMV) were chosen, per ICH/EMA guidelines, to represent a range of viruses with different genome, structure, size, and sensitivity to various chemical and physical agents. The virus spiked hPLs were gamma irradiated and the mean values of viral titers showed over 4 log10 reductions across all model viruses. The results demonstrated gamma irradiation is an effective viral reduction procedure for hPL.To assess the impacts of gamma irradiation on the long-term stability of hPL performance, we analyzed UltraGRO™ GI series up to one year after gamma irradiation. The results showed growth factors still retained comparable levels to the non-irradiated hPLs. Mesenchymal stromal cells (MSC) cultured with gamma-irradiated hPLs for more than three passages showed similar profiles as with the corresponding non-irradiated hPLs in respect of growth rate, morphology, immunophenotype, trilineage differentiation potency, and immunosuppressive properties.
Source: Cytotherapy - Category: Cytology Source Type: research