Abstract
Purpose :
Compounding and storing of intravitreal anti-VEGF agents in syringes is commonly performed in an off-label manner with the goal to increase cost effectiveness. However, preservation of compound integrity must be guaranteed. The aim of this study was to compare the chemical and physical stability, sterility, and the biophysical stability of faricimab, a bispecific anti-VEGF/ANG-2 biologic, after compounding and storage in silicone oil-free and silicone oil-containing polypropylene syringes for up to 28 days.
Methods :
Faricimab was drawn into silicone oil-free (Zero Residual™ 0,2ml, SJJ Solutions, The Netherlands) and silicone oil-containing (BD MicroFine™ 0,3ml, Becton Dickinson, USA) polypropylene syringes under controlled aseptic conditions and stored under light protection at 2°C to 8°C for up to 28 days. Faricimab taken from freshly punctured glass vials was used as control. Binding affinity to VEGF and ANG-2 was measured using grating-coupled interferometry. Size-exclusion chromatography with multi-angle light scattering and nano differential scanning fluorimetry-based thermal stability evaluation were used for chemical stability analysis. Microbiological evaluation of sterility was performed. One-way ANOVA test was used to analyze statistical significance (p ≤0.05).
Results :
No significant differences in VEGF and ANG-2 binding affinity were found in faricimab samples stored in either syringe type over 28 days compared to control. Chemical stability testing revealed no statistically significant variation in molecular mass of the monomer or presence of degradation products. A low dimerization grade was already present in the control samples and did not show any trend after 28 days. Thermal stability of all samples was identical and microbiological analysis did not detect contamination.
Conclusions :
No differences in drug binding properties, chemical stability, or sterility of faricimab were found in silicone oil-free and silicone oil-containing syringes. Our findings confirm the pharmaceutical safety of compounded faricimab after storage for up to 28 days. This may facilitate a cost effective off-label use of faricimab in clinical practice.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.