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RESEARCH PRODUCT

The Effect of Fluctuating Temperature on the Stability of Turoctocog Alfa for Hemophilia A

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Abstract Background and objective Factor VIII (FVIII) is indicated for the prevention or treatment of bleeding in patients with hemophilia A. FVIII product stability under high and fluctuating temperatures is important, particularly for patients who reside in, or travel to, regions with high ambient temperatures, as they may remove their product from the refrigerator and return it, unused, multiple times. We evaluated the effect of variable temperature storage conditions, including up to 40 °C, on the stability of the recombinant FVIII product, turoctocog alfa. Methods Turoctocog alfa dry powder stability was assessed when moved between storage conditions of 5 °C (ambient humidity) and 40 °C (75% relative humidity) multiple times over a 2-month period, followed by long-term storage at 40 °C for 3 months and 5 °C for 1 month. Three product strengths (250, 1500, and 3000 IU), including the lowest and highest doses, were evaluated. Stability assessments included potency, purity, oxidized forms, high molecular weight protein (HMWP), and water content. Results Overall, the three doses of turoctocog alfa tested remained stable under varying temperature conditions, without any potency or purity impairment, nor were any major increases in oxidized forms, HMWP, or water content observed. All results were within shelf-life specification limits. Conclusion The results demonstrated that turoctocog alfa can be subjected to variable storage conditions, including cycling between 5 °C and ≤ 40 °C, and subsequent storage for 3 months up to 40 °C, without loss of stability. This suggests that turoctocog alfa may offer greater product storage flexibility for patients in everyday practice, with a potential reduction in wastage.