Division of Biotherapeutics, National Institute for Biological Standards and Control, Hertfordshire EN6 3QG, UK.
Division of Technology Development and Infrastructure, National Institute for Biological Standards and Control, Hertfordshire EN6 3QG, UK.
Biomolecules. 2021 Oct 30;11(11):1610. doi: 10.3390/biom11111610.
Several Bevacizumab products are approved for clinical use, with many others in late-stage clinical development worldwide. To aid the harmonization of potency assessment across different Bevacizumab products, the first World Health Organization (WHO) International Standard (IS) for Bevacizumab has been developed. Two preparations of a Bevacizumab candidate and comparator were assessed for their ability to neutralize and bind vascular endothelial growth factor (VEGF) using different bioassays and binding assays in an international collaborative study. Relative potency estimates were similar across different assays for the comparator or the duplicate-coded candidate sample. Variability in relative potency estimates was reduced when the candidate standard was used for calculation compared with various in-house reference standards, enabling harmonization in bioactivity evaluations. The results demonstrated that the candidate standard is suitable to serve as an IS for Bevacizumab, with assigned unitages for VEGF neutralization and VEGF binding activity. This standard coded 18/210 was established by the WHO Expert Committee on Biological Standardization, which is intended to support the calibration of secondary standards for product development and lifecycle management. The availability of IS 18/210 will help facilitate the global harmonization of potency evaluation to ensure patient access to Bevacizumab products with consistent safety, quality and efficacy.
有几种贝伐珠单抗产品已获得临床批准，全球还有许多其他产品处于临床开发后期。为了促进不同贝伐珠单抗产品效力评估的标准化，世界卫生组织（世卫组织）首次制定了贝伐珠单抗国际标准（IS）。在一项国际合作研究中，使用不同的生物测定法和结合测定法评估了候选贝伐珠单抗的两种制剂及其对血管内皮生长因子（VEGF）的中和和结合能力。候选品和参比制剂的相对效力估计值在不同的测定法中相似。与各种内部参考标准相比，当使用候选标准进行计算时，相对效力估计值的变异性降低，从而实现了生物活性评估的标准化。结果表明，候选标准适合作为贝伐珠单抗的 IS，其 VEGF 中和和 VEGF 结合活性的单位已被指定。该标准由世卫组织生物标准化专家委员会编码为 18/210，旨在支持为产品开发和生命周期管理校准二级标准。IS 18/210 的可用性将有助于促进效力评估的全球标准化，以确保患者能够获得具有一致安全性、质量和疗效的贝伐珠单抗产品。
