INTERCEPT plasma: comparability with conventional fresh-frozen plasma based on coagulation function--an in vitro...

Area of Science:

• Blood product safety
• Transfusion medicine
• Biotechnology

Background:

• Effective pathogen inactivation (PI) is crucial for plasma safety.
• PI technologies must maintain haemostatic function for therapeutic use.
• The INTERCEPT Blood System is a PI technology for plasma.

Purpose of the Study:

• Evaluate coagulation factor functionality in INTERCEPT-treated plasma (I-FFP).
• Assess the impact of amotosalen and UVA treatment on plasma proteins.
• Determine if haemostatic function is retained post-treatment.

Main Methods:

• Apheresis plasma was treated with amotosalen and UVA.
• Plasma aliquots were analyzed before and after photochemical treatment.
• Analysis included pro-coagulants, inhibitors, fibrinolytic proteins, contact factors, activation markers, von Willebrand complex, and complement proteins.

Main Results:

• Procoagulant factor retention was 77-92%.
• Von Willebrand complex components and activity were maintained.
• Endogenous inhibitors, plasminogen, and alpha-2 antiplasmin were largely retained.
• Coagulation activation markers remained within normal ranges, with minimal exceptions.
• Complement activation markers (anaphylatoxins) did not increase; C1-esterase inhibitor was fully retained.

Conclusions:

• INTERCEPT Blood System treatment preserves key haemostatic proteins in plasma.
• The treatment does not cause inappropriate activation of coagulation, fibrinolytic, or complement pathways.
• I-FFP maintains haemostatic function suitable for therapeutic support.