Implementation of a UVC-based pathogen reduction treatment for apheresis platelets at a regional blood service in Germany

Background

Until now, pathogen reduction treatment for platelet concentrates (PCs) is not mandatory in Germany. Nevertheless, the Bavarian Red Cross Blood Service started to implement the THERAFLEX UV-Platelets System (Macopharma) as effective and preventive measure to increase blood safety. The UVC-based system for PCs was validated as required for manufacturing license and marketing authorization approval.

Methods

Six double apheresis PCs were collected and split into 12 single units. Six PCs were treated with the THERAFLEX UV-Platelets System, while the other six corresponding PCs were left untreated and served as control. Pathogen reduction of PCs using the THERAFLEX UV-Platelets System was performed under routine-like conditions. PCs were stored under agitation at 22 +/- 2 °C and samples were collected on day 2, day 6 and day 9. Platelet in vitro quality parameters were tested according to the local standard operation procedures. Manufacturing steps of the THERAFLEX UV-Platelets procedure were validated, and UVC treatment was monitored in the platelet units using a mitochondrial DNA multiplex real-time polymerase chain reaction inhibition assay.

Results

Platelet content per unit was between 3,12 x 10¹¹ and 3,75 x 10¹¹ (mean 3,43 x 10¹¹) in UVC-treated PCs and between 3,25 x 10¹¹ and 3,91 x 10¹¹ (mean 3,56 x 10¹¹) in control units. Pathogen-reduced and untreated PCs showed similar result in swirling and hypotonic shock reaction until day 9 and were tested negative for anaerobic and aerobic bacterial growth. During time of storage glucose concentration decreased and lactate concentration increased in all units. Glucose consumption was higher in UVC-treated units than in untreated units; however, glucose was still present on day 9. The mitochondrial polymerase chain reaction analysis correctly discriminated between UVC-treated and untreated PCs.

Conclusion

UVC treatment of apheresis PCs is a fast and easy procedure and was successfully integrated into the local manufacturing processes. All UVC-treated PCs fulfilled the specifications of the THERAFLEX UV-Platelets technology and met the requirements of the German guidelines for pathogen-reduced PCs.

Offenlegung Interessenkonflikt:

Macopharma supports the work with project grants for the development of UVC-based PI technology of platelets.

Research Foundation of the German Red Cross Blood Services supports the work with project grants for the development of UVC-based PI technology of platelets.