Pathogen reduction treatment
Human platelet lysate (hPL) contains abundant growth factors and cytokines necessary for cell growth and is well recognized as an efficient xenogenic-free alternative to FBS for manufacturing cells and cellular products.
With cGMP and pathogen risk assessment in mind, all platelet units for manufacturing UltraGRO™ products are sourced from FDA-licensed, AABB Accredited US blood centers. Each platelet donor has been interviewed, evaluated, and donations are tested using FDA-licensed tests for infectious diseases screening. All donors' blood must test negative for all pathogens screened before donation is determined suitable for use. To further minimize the risk of pathogen transmission, a detailed tracking system with blood banks is implemented. All platelet units received by AventaCell will be verified and recorded then held for a holding period. If a donation tested negative upon collection but the donor tests positive in their next donation, the inventory hold period allows an opportunity for the blood bank notification system to help exclude any suspicious unit from being used in manufacturing. Furthermore, our cGMP manufacturing system prevents adventitious pathogen contamination from occurring during manufacturing.
In addition, because these “window-phase” donors cannot be screened at the time of platelet collection, AventaCell has adopted a state-of-the-art gamma irradiation process, as a pathogen reduction treatment (PRT) for viral inactivation, to create the UltraGRO™ GMP PRT products. Gamma irradiation of finished product disrupts the nucleus acids of viral genomes and inactivate their infectious capability. We have validated the efficacy of our gamma irradiation process for virus inactivation while demonstrating low impact on our hPL products’ potency and long-term stability.
The UltraGRO™ GMP PRT products offer a higher safety standard with optimally minimized pathogen contamination risk while preserving potent cell culture performance with human MSC, immune cells, and other applicable cell types for clinical and commercial applications.