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Porcine factor VIII (Hyate: C®): in vitro stability, microbiological safety and effect of heparin
S F Travis1, N Burns1, P Hofmann1
1Regional Comprehensive Hemophilia Center, Cooper Hospital University Medical Center, UMDNJ-Robert Wood Johnson Medical School at Camden, Camden, New Jersey 08103, USA.
Abstract:
The in vitro stability of porcine factor VIII (PF VIII) was evaluated when it was reconstituted with sterile water (PF VIIISW ) to ≈ 30 U PFVIII mL(-1) , as per the manufacturer's recommendations, and stored in plastic syringes at room temperature, with and without heparin and at four different dilutions. PF VIII was prepared antiseptically without laminar airflow and remained sterile at room temperature for 1 week. PF VIIISW retained at least 88% of baseline activity for 48 h and 74-86% for 72 h. Addition of heparin 1 unit mL(-1) solution resulted in a decrease in the stability of PF VIIISW to 72-74 % of baseline values by 24 h. Reconstituted PF VIIISW , further diluted with normal saline to 10-24 U PF VIII mL(-1) , retained 98% of baseline activity for 48 h and 84% of baseline for 72 h. PF VIII diluted to 6 U mL(-1) , however, retained 100% baseline activity for only 24 h, and declined to 71% and 64 % of baseline by 48 and 72 h, respectively. PF VIII reconstituted with normal saline, instead of sterile water, retained 90% or more of baseline activity for a minimum of 4 days. Once reconstituted, PF VIII appeared to be more stable at room temperature than when stored in the refrigerator. These in vitro stability studies confirm that PF VIII (30 U mL(-1) ) can be given effectively by prolonged continuous infusion, since it retains 88% baseline activity at room temperature in a plastic syringe for a minimum of 48 h, remains sterile and will maintain baseline PF VIII levels when further diluted with saline.
Insights
Porcine factor VIII (PF VIII) stability was assessed in plastic syringes. PF VIII remained stable for 48 hours at room temperature, supporting its use in prolonged infusions.
Area of Science:
- Biochemistry
- Pharmacology
- Hematology
Background:
- Porcine factor VIII (PF VIII) is a crucial therapeutic agent for hemophilia.
- Understanding the in vitro stability of PF VIII is essential for optimizing its clinical application, particularly in continuous infusion protocols.
Purpose of the Study:
- To evaluate the in vitro stability of reconstituted porcine factor VIII (PF VIII) under various storage conditions.
- To determine the impact of different diluents, concentrations, and the presence of heparin on PF VIII's biological activity over time.
Main Methods:
- Porcine factor VIII was reconstituted with sterile water or normal saline to approximately 30 U/mL.
- Samples were stored in plastic syringes at room temperature, with and without heparin, and at dilutions ranging from 6 to 24 U/mL.
- Factor VIII activity was measured at various time points (24, 48, and 72 hours) to assess stability.
Main Results:
- PF VIII reconstituted with sterile water retained at least 88% activity for 48 hours and 74-86% for 72 hours at room temperature.
- Addition of heparin (1 U/mL) decreased PF VIII stability to 72-74% activity by 24 hours.
- Dilution with normal saline to 10-24 U/mL maintained 98% activity for 48 hours and 84% for 72 hours; however, dilution to 6 U/mL showed reduced stability.
- PF VIII reconstituted with normal saline was stable for at least 4 days at room temperature and appeared more stable at room temperature than refrigerated storage.
Conclusions:
- Reconstituted PF VIII (30 U/mL) in plastic syringes is stable for at least 48 hours at room temperature, supporting its use in prolonged continuous infusions.
- Dilution with normal saline enhances PF VIII stability compared to sterile water alone.
- Heparin negatively impacts PF VIII stability, and lower concentrations (6 U/mL) exhibit reduced shelf-life.
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