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

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-07-25 DOI:10.1007/s12325-025-03319-z

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

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引用次数: 0

Abstract

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.

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XSB-001（雷尼单抗生物类似药）在玻璃体内注射用制备注射器的理化和生物学稳定性评价。

血管内皮生长因子A （VEGF-A）是视网膜疾病（如新生血管性年龄相关性黄斑变性和糖尿病性黄斑水肿）中新血管形成和血管通透性的关键驱动因素。XSB-001 （Ximluci®）是一种雷尼单抗生物类似药，其安全性、有效性和生物活性与参考雷尼单抗相当，支持其在这些适应症中的使用。方法：本研究评价了XSB-001在实际处理条件下30天的延长物理化学和生物稳定性。XSB-001保存在5±3°C的小瓶中，分为两种注射器。样品在监测条件下保存30天，其中一部分暴露于室温、湿度和室内照明或避光48小时。结果：在所有测试条件下，XSB-001在规格限制内保持预期的液体物理状态、透明度和颜色，除了电荷变化。高单体纯度（99.6%）、高分子量物种（0.4%）和低分子量物种(结论：这些结果支持XBS-001在未开封的小瓶中储存并随后制备注射器（与注射器类型无关）的稳定性，优化了患者护理和治疗管理效率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.