Replenine-VF (human plasma derived coagulation factor IX) / Bio Products Lab - LARVOL DELTA

FIX is localised in the vessel wall and can generate thrombin when in complex with collagen IV in human synovial tissues (ISTH 2024) - "On surfaces with the FIX-collagen complex present, FIX-DP generated a peak thrombin concentration comparable to PNP. FIX binding was confirmed by a chromogenic activity assay and a dose-dependent effect of FIX coating concentration was observed. Collagen plates coated with extended half-life concentrates, Alprolix and Idelvion, generated a significant increase in the endogenous thrombin potential (ETP), when compared to short-acting concentrate, Replenine and Benefix (* p < 0.01)."

Hematological Disorders • Hemophilia • Rare Diseases • Thrombosis

[VIRTUAL] Activity Measurement of Factor IX Padua against the 4th International Standard for FIX, Plasma (ISTH 2020) - " Recombinant FIXP was produced and purified from HEK293 cells and Replenine, a plasma-derived FIX was used as a comparator... Assay discrepancies exist when FIXP is assayed against Plasma Standard for FIX. Careful selection of OSCA and CHA is of paramount importance to obtain accurate activity estimates of gene expressed FIXP in patients."

Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases

[VIRTUAL] Activity Measurement of Factor IX Padua against the 4th International Standard for FIX, Plasma (ISTH 2020) - " Recombinant FIXP was produced and purified from HEK293 cells and Replenine, a plasma-derived FIX was used as a comparator... Assay discrepancies exist when FIXP is assayed against Plasma Standard for FIX. Careful selection of OSCA and CHA is of paramount importance to obtain accurate activity estimates of gene expressed FIXP in patients."

Gene Therapies • Hematological Disorders • Hemophilia • Rare Diseases