Aflibercept 生物仿制药 ABP 938 与 Aflibercept 参考产品的分析和功能相似性。

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-05-01 Epub Date: 2024-03-20 DOI:10.1007/s40123-024-00914-1

Neungseon Seo, Xiaoyan Guan, Tian Wang, Hyo S Helen Chung, Mats Wikström, Rupa Padaki, Kevin Kalenian, Scott Kuhns, Kelli Matthies, Jill Crouse-Zeineddini, Helen Y Wong, Michael Ng, Ian N Foltz, Shawn Cao, Jennifer Liu

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引用次数: 0

摘要

简介：ABP 938正在开发中，是阿弗利贝赛普参比品（RP）的候选生物仿制药，阿弗利贝赛普参比品是一种用于治疗某些血管性眼病的生物制剂。本研究旨在对ABP 938和来自美国（US）和欧盟（EU）的aflibercept RP的结构和功能属性进行比较分析评估：采用最先进的分析技术进行结构和功能表征研究，这些技术适合评估相关质量属性，能够检测一级结构、高阶结构和生物物理性质、产品相关物质和杂质、一般性质和生物活性的定性和定量差异：ABP 938 与阿弗利百普 RP 具有相同的氨基酸序列、相似的二级和三级结构以及生物活性。少数生化属性存在细微差别，但预计不会影响临床表现。此外，来自美国和欧盟的阿弗利百普RP在分析上也很相似：ABP 938在结构上和功能上与阿弗利百普RP相似。结论：ABP 938 在结构和功能上与阿弗利百普 RP 相似，由于来自美国和欧盟的阿弗利百普 RP 在分析上相似，因此可以建立科学桥梁，使单一来源的 RP 可用于非临床和临床研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product.

查看原文本刊更多论文

Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product.

Introduction: ABP 938 is being developed as a biosimilar candidate to aflibercept reference product (RP), a biologic used for certain angiogenic eye disorders. This study was designed to provide a comparative analytical assessment of the structural and functional attributes of ABP 938 and aflibercept RP sourced from the United States (US) and the European Union (EU).

Methods: Structural and functional characterization studies were performed using state-of-the-art analytical techniques that were appropriate to assess relevant quality attributes and capable of detecting qualitative and quantitative differences in primary structure, higher-order structure and biophysical properties, product-related substances and impurities, general properties, and biological activities.

Results: ABP 938 had the same amino acid sequence and exhibited similar secondary and tertiary structures, and biological activity as aflibercept RP. There were minor differences in a small number of biochemical attributes which are not expected to impact clinical performance. In addition, aflibercept RP sourced from the US and EU were analytically similar.

Conclusions: ABP 938 was structurally and functionally similar to aflibercept RP. Since aflibercept RP sourced from the US and EU were analytically similar, this allows for the development of a scientific bridge such that a single-source RP can be used in nonclinical and clinical studies.

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and 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. 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