Alphanine SD (coagulation factor IX [human]) / Grifols - LARVOL DELTA

Evaluation of recovery of factor IX replacement therapy with HemosIL Chromogenic Factor IX (ISLH 2024) - "HemosIL Chromogenic Factor IX demonstrated the ability to correctly measure FIX activity in plasma pools with 3 FIX replacement therapies: Alpha Nine SD, BeneFIX, and REBINYN. Results with albutrepenonacog alpha (recombinant FIX fused with recombinant human albumin; Idelvion) demonstrated over recovery of 59% when compared to the theoretical value based on the potency assignment by the manufacturer. In 2019 Rosén et al."

Hematological Disorders • Hemophilia • Rare Diseases

Performance of a Chromogenic Factor IX Activity Assay in the Recovery of Factor IX Replacement Therapies (ISTH 2022) - "Aims: To evaluate the recovered activity of seven FIX replacement products including AlphaNine SD, Alprolix, BeneFIX, Idelvion, Rebinyn, Ixinity and Rixubis by a new chromogenic FIX assay. Using acceptance criteria of 100 ± 25 percent recovery, the Chromogenic Factor IX assay accurately quantified 6/7 products across all levels including AlphaNine, Alprolix, BeneFIX, Rebinyn, Ixinity and Rixubis. The mean FIX recovery was 96, 116, 93, 82, 117 and 102% respectively, relative to the theoretical target across all tested levels. There was an over-recovery of Idelvion (albumin fusion recombinant FIX) with a mean recovery of 153%."

Hematological Disorders • Hemophilia • Rare Diseases

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

Do patients with haemophilia undergoing cardiac surgery have good surgical outcomes? (Interact Cardiovasc Thorac Surg) - Life expectancy of haemophilia patients is increasing & now approaches that of general male population & they are confronted with age-related co-morbidity, including ischaemic cardiovascular disease; Replacement of deficient factor (VIII for haemophilia A & IX for haemophilia B) is cornerstone of treatment

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