The sterility, stability and efficacy of repackaged ziv-aflibercept for intravitreal administration

To evaluate the sterility, stability, and efficacy of repackaged ziv-aflibercept in 1-mL plastic tuberculin syringes for intravitreal injection after storage for up to 90 days at controlled (4 degrees C) and ambient (25.8 degrees C) temperature. A total of 168 tuberculin-type 1-mL syringes were prepared containing ziv-aflibercept (100 mg/4 mL). Samples were stored at 4 degrees C and 25.8 degrees C for 0, 3, 7, 14, 21, 28, 60, and 90 days. At each time point, four samples were evaluated for the stability and binding affinity of anti-VEGF to VEGF (efficacy) using enzyme-linked immunosorbent assays (ELISAs). All samples were analyzed for microbial growth. No microbial growth was obtained from any of the ziv-aflibercept samples during each time point, indicating that the repackaged ziv-aflibercept stored at 4 degrees C and 25.8 degrees C remained sterile. ELISA analysis revealed no significant decrease in concentration, and binding affinity was observed, indicating that the stability and efficacy were preserved. However, the concentration of ziv-aflibercept decreased less than the minimum expected concentration of 8 ng/mL after 60 days at 4 degrees C and after 30 days at 25.8 degrees C. The repackaged anti-VEGF drug ziv-aflibercept does not lose stability or efficacy and remains uncontaminated if prepared under sterile conditions and stored at 4 degrees C for up to 60 days or stored at 25.8 degrees C for up to 30 days.

Automated summary

This study evaluated the sterility, stability, and efficacy of repackaged ziv-aflibercept stored in plastic tuberculin syringes for up to 90 days at controlled and ambient temperature. The results showed that the repackaged ziv-aflibercept remained sterile and stable, with preserved efficacy. However, the concentration of the drug decreased after a certain period of time at specific temperatures.