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In-vitro stability of porcine factor VIII (Hyate:C(®) )
D M Woloschuk1, M Rubinger1, S J Israels1
1Department of Pharmaceutical Services, Health Sciences Centre, 820 Sherbrook Street, Winnipeg, Manitoba and Coagulation Laboratory, Manitoba Cancer Treatment and Research Foundation, 100 Olivia Street, Winnipeg, Manitoba, Canada.
Summary
Porcine factor VIII (Hyate:C®) stability was assessed in sodium chloride injection. Higher concentrations (15-30 units/mL) remained stable for up to 72 hours at room temperature, while lower concentrations (5 units/mL) were stable for 24 hours.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Biotechnology
- Hematology
Background:
- Porcine factor VIII (Hyate:C®) is a critical treatment for hemophilia A.
- Understanding its stability in various conditions is essential for effective therapeutic use, especially in ambulatory settings.
- Previous studies have not fully elucidated the stability profile of Hyate:C® at different concentrations and storage conditions relevant to infusion pumps.
Purpose of the Study:
- To evaluate the stability of porcine factor VIII (Hyate:C®) at different concentrations (5, 15, and 30 units/mL) when prepared in 0.9% sodium chloride injection.
- To determine the impact of storage conditions (room temperature with ambient light vs. body temperature protected from light) on Hyate:C® activity over time.
- To provide data supporting the potential use of Hyate:C® in ambulatory infusion pumps.
Main Methods:
- Porcine factor VIII (Hyate:C®) solutions at 5, 15, and 30 units/mL were aseptically prepared in 0.9% sodium chloride injection.
- Solutions were stored in plastic syringes under two conditions: room temperature with ambient light, and 37°C (body temperature) protected from light.
- Factor VIII (FVIII) activity was measured using a one-stage FVIII assay at baseline, 4, 24, 48, and 72 hours. Stability was defined as no more than a 10% decline in FVIII activity from baseline.
Main Results:
- Hyate:C® 5 units/mL retained >90% activity for at least 24 hours at room temperature but declined to <90% within 4 hours at body temperature.
- Hyate:C® 15 and 30 units/mL retained >90% activity for at least 72 hours at room temperature.
- At body temperature, Hyate:C® 15 and 30 units/mL retained >90% activity for 24 hours.
Conclusions:
- Porcine factor VIII (Hyate:C®) demonstrates concentration-dependent stability in 0.9% sodium chloride injection.
- Higher concentrations of Hyate:C® exhibit greater stability, particularly at room temperature, making them potentially suitable for extended ambulatory administration.
- Further evaluation is warranted to confirm Hyate:C® stability in ambulatory infusion pumps based on these findings.
