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

INTRODUCTION: ), 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.