Pharmaceutical Compounding, Storage of Faricimab Preserves Stability, Binding Properties
Maintaining the structure and function of antibody biologics like faricimab is critical for their administration via intravitreal injection (IVI), a common treatment approach for retinal diseases.
Withdrawing and storing faricimab in syringes for up to 37 days does not alter the therapeutic antibody’s structure or its bi-specific antigen-binding properties, according to new research published in the International Journal of Retina and Vitreous.1
In contrast to previous intravitreal injection (IVI) therapeutic antibodies that only target vascular endothelial growth factor A (VEGF-A) when treating retinal diseases, the newly available faricimab offers a broader approach by inhibiting both VEGF-A and angiopoietin-2 (Ang-2).
Although faricimab has demonstrated favorable efficacy and durability in its treatment of diseases like neovascular age-related macular degeneration, little is known about the effects of pharmaceutical compounding on prefilled syringes of the drug, especially as they differ from former antibodies. Investigators in the current study sought to understand whether the first-in-class faricimab can be safely withdrawn and stored in syringes for up to 37 days.
Using Zero Residual silicone oil-free filter needles and the auxiliary Zero Residual Bubble Adapter, investigators withdrew faricimab from vials and prefilled a total of 72 Zero Residual silicone oil-free, 0.2 mL syringes for evaluation.
To determine whether syringe withdrawal affects faricimab, investigators compared syringes prepared at day 0 with a mounted needle (D0-n) to samples measured directly from faricimab vials. To determine whether syringe storage affects faricimab, investigators compared faricimab from prefilled syringes in the dark at 4°C for either 7, 14, or 37 days with D0-n.
Investigators found that neither the effect of withdrawal nor storage of faricimab in the Zero Residual silicone oil-free, 0.2-mL syringe negatively affected concentration, integrity, aggregation, or thermal stability of the drug. Further, faricimab retained its ability to bind to VEGF-A and Ang-2 through 37 days and did not bind the neonatal Fc receptor (FcRn) under any conditions, illustrating the suitability of pharmaceutical compounding and storage practices for preserving the structure and function of the therapeutic antibody.
It is of the utmost importance that syringes used in pharmaceutical compounding processes be able to both preserve the drug and accurately administer it intravitreally, thus avoiding possible drug-syringe interactions. If done successfully, pharmaceutical compounding of prefilled syringes for IVI can optimize hygiene standards, save clinician time, and allow for splitting of vials to reduce costs.
Given these potential benefits, investigators noted the importance of selecting an appropriate syringe for pharmaceutical compounding processes.
“The Zero Residual syringe incorporates several favorable features: high accuracy and precision, no silicone oil, Luer Lock (ie, no fixed needle), and negligible dead volume,” study authors said.1 “A previous study from our group also showed that it could store bevacizumab, ranibizumab, and aflibercept without compromising their functional binding, stability, or FcRn-mediated cellular recycling."2
Although this study was successful in determining how withdrawal and storage affects the drug stability of faricimab, study limitations exist. Firstly, the prefilled syringes were not tested in a clinical setting, but rather an in vitro study. Secondly, while the syringes were filled under controlled aseptic conditions, their sterility was not assessed, an important factor in any pharmaceutical compounding procedure.
