Sterility of repackaged faricimab for intravitreal administration
Antonio Raymundo1, Lourdes Cervera2, Francisco Crespillo1
1Department of Pharmacy, HLA-Vistahermosa Hospital, Alicante, Spain.
Objectives:
New drugs such as faricimab have been developed to treat ophthalmic neovascular diseases. While these drugs increase treatment success, they also increase costs. Repackaging drugs strikes a balance between technical requirements and treatment flexibility. The aim of this study was to evaluate the microbiological stability of repackaged faricimab under controlled conditions in order its already demonstrated chemical, biological, and microbiological stability.
Methods:
This was a prospective, controlled experimental study. The contents of four vials of faricimab were repackaged into 16 silicone oil-free syringes with a low dead space volume. A bubble adaptor was used to ensure the maximum efficiency from fractioning. All samples were stored at 2-8 °C. Four of the syringes were cultivated on blood and Sabouraud agar at set time points (9 days, 16 days, 23 days, and 30 days). The endpoint of the study was positive microbiological growth in any of the samples. Negative and positive controls were cultivated alongside the test samples.
Results:
None of the 16 samples or the negative controls exhibited microbiological growth at any stage of the culturing process. All positive controls showed microbiological growth.
Conclusions:
When repackaged in silicone oil-free syringes, faricimab retains microbiological stability for up to 30 days when it is prepared and stored under controlled conditions.
