PB1233 - Stability of Omfiloctocog alfa (SCT800) for Continuous Infusion in Hemophilia A Treatment

Background: Continuous infusion (CI) of coagulation factor VIII (FVIII) has shown promise in maintaining steady plasma levels, reducing bleeding risk, and conserving FVIII concentrates. Omfiloctocog alfa (SCT800), a recombinant FVIII (rFVIII), is the first domestically produced rFVIII in China designed for managing and preventing bleeding in individuals with hemophilia A, including its application in surgical procedures.

Aims: This study aims to assess the stability of SCT800 after reconstitution and its suitability for continuous infusion.

Methods: SCT800, provided in lyophilized powder form, is reconstituted with 4 mL of sterilized injection water. Stability experiments involved measuring FVIII activity using the chromogenic substrate assay (BIOPHEN™ FVIII). Clinical evaluation of FVIII activity was conducted using a one-stage assay.

Results: Stability experiments revealed that the reconstituted product remains stable for at least 48 hours when stored at room temperature or even at 37℃, enabling continuous administration (Fig. 1). A patient undergoing continuous infusion post-surgery had the diluted SCT800 solution syringe changed every 6 hours, maintaining steady FVIII levels as depicted in Figure 2. Furthermore, no FVIII inhibitor was detected.

Conclusion(s): Preliminary data from this study confirm the stability of SCT800, indicating its suitability for continuous infusion. This finding holds significant promise for the effective management of hemophilia A, particularly in perioperative care.