Performance of a viral clearance study for the development and characterization of a pathogen reduced human platelet lysate to safely and efficiently expand therapeutic stem cells

The central goal of this proposal is to conduct a viral clearance validation study. To meet the growing demand of pathogen reduced hPL used in clinical applications and remain competitive among other platelet lysate manufacturers, we need to adapt our production process to include a pathogen reduction step. The validation of this product is on its final stages. However, it is necessary to perform a viral clearance study to prove that the gamma irradiation applied to the hPL inactivates potential pathogens. The study will be outsourced to Charles River Laboratories, INC. The project to achieve the central goal involves the following goals:

1. Addition or spike of hPL products with different viruses and recovery of infective viral particles: Five appropriate model viruses will be spiked into the sample to determine if they can successfully be recovered in their infective form. This will allow to evaluate any impact, not due to irradiation, that the sample has on the viruses.
2. Gamma irradiation of hPL loaded with test viruses and evaluation of viral inactivation: This goal will involve the study of the ability of gamma irradiation to inactivate viruses from a panel representative of the virus diversity.