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<p>The introduction of high-dose aflibercept (114.3&#xa0;mg/mL) has expanded treatment options for retinal vascular diseases, but data on the stability of compounded high-dose formulations remain limited. The objective of this study was to evaluate the chemical, physical and microbiological stability as well as VEGF-binding activity of high-dose aflibercept after aseptic compounding into two syringe platforms used for intravitreal injection. Aflibercept was aseptically transferred into silicone-oil-containing BD Microfine<sup>®</sup> syringes and silicone-oil-free ZeroResidual<sup>®</sup> syringes and stored at 2–8&#xa0;°C for up to 28 days. Stability was assessed by visual inspection, pH measurement, UV-Vis spectroscopy, dynamic light scattering (DLS), size-exclusion chromatography with static light scattering (SEC-SLS), nano differential scanning fluorimetry (nanoDSF), and a VEGF-binding assay. Sterility and endotoxin levels were evaluated. Across all analyses, aflibercept remained stable in both syringe types. No visible particles or alterations of the tertiary structure were detected, while pH remained constant. DLS revealed a monodisperse particle distribution. SEC-SLS showed no oligomerisation or degradation. NanoDSF demonstrated unchanged thermal stability. VEGF-binding activity was preserved. All samples remained sterile with endotoxin levels below the detection threshold. High-dose aflibercept retains full structural and functional stability for at least 28 days after compounding into BD Microfine<sup>®</sup> or ZeroResidual<sup>®</sup> syringes when stored refrigerated. These findings support the safe use of compounded high-dose aflibercept in intravitreal injection workflows.</p>

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Preserved structural and functional stability of high-dose aflibercept after compounding into prefilled syringes

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月9日

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  • Alexander Taschauer,
  • Daniel Egger,
  • Arthur Sedivy,
  • Audrey Crousilles,
  • Claudia Wunder,
  • Sebastian M. Waldstein

摘要

The introduction of high-dose aflibercept (114.3 mg/mL) has expanded treatment options for retinal vascular diseases, but data on the stability of compounded high-dose formulations remain limited. The objective of this study was to evaluate the chemical, physical and microbiological stability as well as VEGF-binding activity of high-dose aflibercept after aseptic compounding into two syringe platforms used for intravitreal injection. Aflibercept was aseptically transferred into silicone-oil-containing BD Microfine® syringes and silicone-oil-free ZeroResidual® syringes and stored at 2–8 °C for up to 28 days. Stability was assessed by visual inspection, pH measurement, UV-Vis spectroscopy, dynamic light scattering (DLS), size-exclusion chromatography with static light scattering (SEC-SLS), nano differential scanning fluorimetry (nanoDSF), and a VEGF-binding assay. Sterility and endotoxin levels were evaluated. Across all analyses, aflibercept remained stable in both syringe types. No visible particles or alterations of the tertiary structure were detected, while pH remained constant. DLS revealed a monodisperse particle distribution. SEC-SLS showed no oligomerisation or degradation. NanoDSF demonstrated unchanged thermal stability. VEGF-binding activity was preserved. All samples remained sterile with endotoxin levels below the detection threshold. High-dose aflibercept retains full structural and functional stability for at least 28 days after compounding into BD Microfine® or ZeroResidual® syringes when stored refrigerated. These findings support the safe use of compounded high-dose aflibercept in intravitreal injection workflows.