(P-BC-17) Comparison of INT100 and INT200 Illuminator for Preparation of Pathogen Reduced Plasma with Amotosalen and UVA Light

Background/Case Studies: The INTERCEPT^® Blood System for Plasma uses amotosalen and UVA light for the ex vivo preparation of pathogen reduced plasma. The current generation INT100 Illuminator uses fluorescent bulbs (320-400 nm) to deliver a controlled dose of UVA light. A next-generation LED-based illumination device, the INT200, has recently received CE mark approval. The INT200 is not approved in the US.

A study was performed to compare the 12-month stability of amotosalen/UVA light treated plasma illuminated with the INT100 (current generation) or INT200 Illuminator.

Study

Design/Methods: Freshly collected apheresis plasma was pooled and split into equal volume units for treatment using either the INT200 Illuminator or the INT100 Illuminator. After treatment, plasma units were frozen and placed into storage at -18ºC to -25ºC for 12 months. Six paired replicates were thawed at the end of 12 months of storage and stored at 1-6ºC for 5 days post-thaw. Plasma in vitro function parameters were assessed for pooled plasma units prior to treatment (data not shown), post-treatment prior to frozen storage, following 12 months frozen storage, and following thaw and refrigerated storage.

Results/Findings: Data for coagulation factors, inhibitors, VWF, ADAMTS13, and complement proteins as well as thrombin generation capacity were evaluated. There was a single parameter with a statistically significant difference between INT200 and INT100; following 12 months frozen storage, Factor VIII activity was marginally lower in the INT200 illuminated plasma. However, although FVIII activity decreased post thaw, the EDQM and ANSM activity requirements for 0.5 IU/mL FVIII were satisfied and thrombin generation capacity was retained. Overall stability of the parameters assessed was demonstrated for both illuminators following 12 months of frozen storage at -18ºC to -25ºC and subsequent refrigerated storage of thawed plasma for 5 days. Parameters were within previously established literature-based ranges and were comparable between INT200 and INT100 treated plasma.

Conclusions: This study demonstrates that the functionality and quality of amotosalen/UVA light treated plasma illuminated with the INT200 LED Illuminator was maintained following twelve months of frozen storage and 5-days post thaw at 1-6 ◦C and is consistent with plasma illuminated with the INT100 Illuminator.