Human platelet lysate (hPL) contains abundant growth factors and cytokines necessary for cell growth and is well recognized as an efficient xenogeneic-free alternative to FBS for manufacturing cells and cellular products.
With cGMP and pathogen risk assessment in mind, all platelet units for manufacturing UltraGRO product lines are from FDA-licensed, AABB Accredited blood centers. Each donor has been interviewed, evaluated, and donations are tested using FDA-licensed tests for infectious disease screening. All donors' blood must test negative before blood products are suitable for use. To further minimize the risk of pathogen transmission, the tracking system with blood banks is implemented. All received platelet units will be verified and recorded then held for a period. For the donations tested negative upon collection but the donors are diagnosed infection later or detected positive in the second donation, the inventory hold period allows the Recall System of blood banks to exclude the suspicious units from incorporating into manufacture pools. Furthermore, our cGMP manufacturing system prevents adventitious pathogen contamination.
Since unknown pathogens and donors in the infectious “window-phase” cannot be screened at the time of blood collection, AventaCell BioMedical has adopted a state-of-the-art gamma irradiation process, as a pathogen reduction treatment (PRT), for viral inactivation to create an UltraGRO GI product line. The ionic irradiation of gamma-ray will disrupt the nucleus acids of viral genomes and inactivate the infectious capability. We have validated the efficacy of the gamma irradiation process for virus inactivation and demonstrated low impacts on hPL potency and long-term stability.
The UltraGRO GI product line offers a higher safety standard with further minimized pathogen contamination risk while preserving potent cell culture performance with human MSC, immune cells, and other applicable cell types for clinical applications.