Abstracts
Process Validation Studies of the INTERCEPT Blood System for Plasma in Three European Blood Centers
Presented at: 22nd Congress of the Society of French Transfusion Sanguine (SFTS) 2005, 6/27/05 - 6/30/05
Introduction: A photochemical process (PCT) using amotosalen (S-59) and UVA light inactivates a broad spectrum of pathogens in plasma (I-FFP). Phase 3 clinical trials, supported with I-FFP processed in 200mL units using a prototype processing set, demonstrated support of patients with coagulopathies and TTP. The I-FFP system has been improved to treat up to 635 mL plasma units in a single, simplified treatment while maintaining the spectrum of pathogen inactivation.
Methods: The effect of the improved process on coagulation factor activity was evaluated using 90 plasma units collected on Autopheresis C or Haemonetics MCS devices in blood centers in Bergen, Lübeck, and Strasbourg. Pre- and post-PCT samples were assayed for factors I-XI and XIII, proteins C&S (PC, PS), antithrombin (AT), and alpha-2 antiplasmin (AP).
Results: Retention of coagulation factor activity in I-FFP prepared using the improved system was 75-76% for FI and FVIII and 81-97% for all other factors. Coagulation factor retention in 275 units of I-FFP prepared for use in the clinical trials was 77%-78% for FI and FVIII; and 77%-95% for factors II, V, VII, IX, X, and XI. In vitro studies using the prototype set demonstrated 90%-103% retention of FXIII, PC, PS, AT, and AP and retention of vWF:CP activity.
Conclusion: The improved INTERCEPT Plasma processing set produces multiple I‑FFP doses with a single PCT process. Coagulation factor activities using the improved set were similar to I-FFP units used in Phase 3 clinical trials, where I-FFP was shown to provide sufficient levels of coagulation factors for treatment of congenital and acquired coagulopathies and therapeutic plasma exchange of TTP.
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