Assessment of Potential Thrombogenicity in an Animal Model of a Triple Viral Inactivated Factor IX Concentrate Manufactured in Argentina

CUADRA GR

Annals of hematology and oncology

Austin Publishing Group

Año: 2021 vol. 8 p. 1 - 1

2375-7965

he risk of thromboembolism with FIX replacement therapy remains a concern for hemophilic B patients. Previous studies from our laboratory demonstrated that the activated factor content of the FIX Plasma Derived (FIXpd) manufactured at UNC-Hemoderivados was negligible by in vitro assay. Notwithstanding, we considered relevant to study the potential thrombogenic risk of our FIXpd concentrates using a modified stasis animal model. Thereby, different group of rats were tested after FIXpd injection (100 or 200 IU F IX kg-1 with or without heparin), considering samples with a thrombogenic score ≥ 2,0 as potential thrombogenic risk. The mean scores ± SD for the doses of 100 and 200 IU kg-1 in the presence or absence of heparin were 0.25±0.06 and 2.25±0.45 and 1.19±0.26 and 2.81±0.40, respectively. The encouraging data obtained from these animal experiments and results from in vitro tests, support the low thrombotic risk associated with the FIXpd concentrate manufactured in UNC Hemoderi