Haemonine (human plasma derived coagulation factor IX) / ADMA Biologics - LARVOL DELTA

Protein aggregates in plasma-derived factor IX (pdFIX) concentrates support platelet activation and microparticle formation in vitro (WFH 2016) - "While we found in BeneFIX only sporadically small singular particles, pdFIX concentrates contained a lot more particles. Size distribution was different in different pdFIX concentrates. PdFIX supported platelet activation and microparticle formation induced by low concentrations of agonists, while rFIX did not. Removal of protein aggregates from pdFIX prevented the activation effect on platelets, without having and influence on FIX activity."

Biomarker • Hemophilia

Real live, long‐time documentation on the use of a single plasmatic factor IX concentrate (EAHAD 2020) - " The use of a single plasma derived factor IX (pdFIX, Haemonine®) was documented in 8 German patients in a non-interventional study... Long-time documentation showed that the application of the pdFIX was safe and well tolerated and no new and/or unexpected safety findings were observed. A similar positive safety profile needs to be shown for other new generation recombinant FIX products."