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Introduction <p>Vascular endothelial growth factor A (VEGF-A) is a key driver of neovascularization and vascular permeability in retinal diseases such as neovascular age-related macular degeneration and diabetic macular edema. XSB-001 (Ximluci<sup><b>®</b></sup><b>)</b>, a ranibizumab biosimilar has demonstrated equivalent safety, efficacy, and biological activity to reference ranibizumab, supporting its use in these indications.</p> Methods <p>This study evaluates the extended physicochemical and biological stability of XSB-001 under real-world handling conditions for 30&#xa0;days. XSB-001 was stored at 5 ± 3&#xa0;°C in vials and prepared into two syringe types. Samples were maintained under monitored conditions for 30&#xa0;days, with a subset exposed to room temperature, humidity and indoor lighting or protected from light for 48&#xa0;h.</p> Results <p>Across all test conditions, XSB-001 maintained expected liquid physical state, clarity, and color within specification limits, besides charge variants. High monomer purity (99.6%), high molecular weight species (0.4%) and low molecular weight species (&lt; 0.35%) were observed, satisfying all required criteria. Size exclusion–high-performance liquid chromatography (SE-HPLC) analysis confirmed monomer content at 99.6%, surpassing the ≥ 99.0% requirement. Reverse-phase high-performance liquid chromatography (RP-HPLC) showed consistent main peak purity of 97.3%, exceeding the ≥ 97.0% criterion. Strong cation exchange high-performance liquid chromatography (SCX-HPLC) recorded main peak values between 96.5 and 96.6%, meeting the ≥ 96.5% threshold. Acidic (1.7%) and basic species (1.6–1.7%) were consistently within specification limits (≤ 2.5%). Sub-visible particulate analysis indicated particle counts within acceptable limits. Protein concentration was stable across storage conditions, ranging from 9.9 to 10.4&#xa0;mg/ml.</p> Conclusion <p>These findings support the extended stability of XBS-001 stored in unopened vials and subsequently prepared syringes (and independent of syringe type), optimizing patient care and treatment management efficiency.</p>

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Evaluation of XSB-001 (Ranibizumab Biosimilar) Physicochemical and Biological Stability in Prepared Syringes for Intravitreal Injection

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月25日

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  • Robert Björnestedt,
  • Sean Waters,
  • Aušrinė Paišytė,
  • Fabricio Furlan,
  • Christian Wanner

摘要

Introduction

Vascular endothelial growth factor A (VEGF-A) is a key driver of neovascularization and vascular permeability in retinal diseases such as neovascular age-related macular degeneration and diabetic macular edema. XSB-001 (Ximluci®), a ranibizumab biosimilar has demonstrated equivalent safety, efficacy, and biological activity to reference ranibizumab, supporting its use in these indications.

Methods

This study evaluates the extended physicochemical and biological stability of XSB-001 under real-world handling conditions for 30 days. XSB-001 was stored at 5 ± 3 °C in vials and prepared into two syringe types. Samples were maintained under monitored conditions for 30 days, with a subset exposed to room temperature, humidity and indoor lighting or protected from light for 48 h.

Results

Across all test conditions, XSB-001 maintained expected liquid physical state, clarity, and color within specification limits, besides charge variants. High monomer purity (99.6%), high molecular weight species (0.4%) and low molecular weight species (< 0.35%) were observed, satisfying all required criteria. Size exclusion–high-performance liquid chromatography (SE-HPLC) analysis confirmed monomer content at 99.6%, surpassing the ≥ 99.0% requirement. Reverse-phase high-performance liquid chromatography (RP-HPLC) showed consistent main peak purity of 97.3%, exceeding the ≥ 97.0% criterion. Strong cation exchange high-performance liquid chromatography (SCX-HPLC) recorded main peak values between 96.5 and 96.6%, meeting the ≥ 96.5% threshold. Acidic (1.7%) and basic species (1.6–1.7%) were consistently within specification limits (≤ 2.5%). Sub-visible particulate analysis indicated particle counts within acceptable limits. Protein concentration was stable across storage conditions, ranging from 9.9 to 10.4 mg/ml.

Conclusion

These findings support the extended stability of XBS-001 stored in unopened vials and subsequently prepared syringes (and independent of syringe type), optimizing patient care and treatment management efficiency.