Plasma

INTERCEPT Blood System for Plasma

The risks of patient exposure to pathogenic agents that may cause transfusion-transmitted infectious disease (TTI) have not been eliminated by current blood safety measures. Those risks remain inherent throughout the process of collecting, testing, manufacturing and distributing plasma for transfusion. In addition, storing liquid plasma for a prolonged time as part of the trauma unit preparedness, holds the risk of bacterial growth.

Repeated exposures to multiple donors during Therapeutic Plasma Exchange (TPE) increases the risk of transfusion-transmitted infections (TTI).

The INTERCEPT Blood System for plasma is used to inactivate a broad spectrum of viruses, bacteria, protozoa and contaminating donor leukocytes in plasma components. As such, it can greatly reduce the risk of transfusion-transmitted diseases and adverse immune reactions associated with transfusion of plasma.

The INTERCEPT Blood System for plasma has been extensively evaluated in a series of clinical studies, all of which met their primary endpoints. Altogether these clinical trials involved more than 600 plasma recipients (42 healthy volunteers and 203 patients in the phase I/II/III studies and in addition 458 patients in post-marketing studies). The studies addressed plasma therapies for disorders including congenital coagulopathies, acquired coagulopathies or disorders requiring therapeutic plasma exchange. The use of INTERCEPT plasma has been  officially approved for all these therapies as part of the class III CE mark as well as from a number of national regulatory agencies including ANSM (France), PEI (Germany) and Swissmedics (Switzerland).

Following CE Mark approval for the INTERCEPT Blood System for plasma in Europe, Cerus initiated a hemovigilance programme to collect additional safety experience with INTERCEPT plasma. The complete INTERCEPT plasma hemovigilance study included data for 9,667 patients from Belgium, France, and Spain involving  57,171 INTERCEPT plasma transfusions. The study included 440 infants and 355 children. The experience from this hemovigilance programme indicates that INTERCEPT plasma exhibits a safety profile comparable to that of conventional plasma. Since 2015 ANSM annual reports have documented a general increase in overall allergic TRs associated with all types of plasma: From 63 per 100,000 plasma components issued in 2015 to 98 per 100,000 in 2020. Annual increases in allergic TR rates have been observed for both INTERCEPT and quarantine plasma since 2016.

The INTERCEPT Blood System for plasma offers the possibility to produce therapeutic plasma units from local donors or from male donors exclusively, which means an increased control over the quality and origin of the plasma product and its related costs.