Novel UV illumination method following riboflavin treatment of whole blood product to optimize pathogen inactivation and reduce cellular damage

CERSI Collaborators: Magali J. Fontaine MD PhD, Paul Buehler PharmD, PhD, Raymond Goodrich, PhD
FDA Collaborators: Carlos Villa, PhD; Jaro Vostal, PhD; CD Atreya, PhD
Project Start Date: January 10, 2024

Regulatory Science Challenge:

Investigators have been studying the methods available to mitigate the risk of transfusion transmitted infection by applying a pathogen reduction technology (PRT) to blood products. Their goal is to improve the technology by increasing the efficacy of the pathogen inactivation while maintaining the function of the blood component being treated.

The need for PRT application to the blood supply is met by treating the blood product with a molecule that inhibits pathogens from replicating and by irradiating the product with ultra-violet (UV) light. UV light is applied on the surface of the bag containing the blood product and is not efficiently targeting the blood components inside the bag. Thus, investigators propose to test a new system allowing the content of the blood product to flow through a tube while being illuminated with the UV light.

Project Description and Aims/Goals:

The goal of this project is to test a PRT system with which the content of the blood product is treated more efficiently, while preserving the integrity and function of the blood component. The system consists of allowing the content of the blood product to flow through a tube while being illuminated with the UV light. The data collected will be based on first, the level of inactivation of pathogens (introduced artificially into the product) and second, on the measurements of functional parameters of each blood component.

Anticipated Outcomes/Impact:

The primary deliverable will be the validation of the PRT system using a novel UV illumination method of the blood product using a flow device compared to a direct UV illumination on the bag. Indeed, this novel method will provide a more uniform treatment of the components with improvement in the quality of the PR-treated blood product.
Upon completion of the studies, the data will be presented in a publication as a new method for pathogen inactivation of blood products with improved efficacy and preservation of the integrity and function of the blood components.