抗VEGF单克隆抗体（PRO-169）的糖基化差异及其与贝伐单抗的广泛比较。

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2023-09-23 DOI:10.1016/j.biologicals.2023.101711

Mayra G. Quiñonez-Alvarado , Paulina Chávez-Hurtado , Jesús C. Caro-Palomera , Oriana L. Niño-Trejo , José I. Jiménez-Dolores , Patricia Muñoz-Villegas , Leopoldo Baiza-Durán , Juan D. Quintana-Hau

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引用次数: 0

摘要

PRO-169是一种抗VEGF单克隆抗体，由索菲亚实验室开发，与贝伐单抗（BVZ）共享其序列；然而，PRO-169是用于玻璃体内给药。在本研究中，分析表征表明，与BVZ参考产物（RP）相比，PRO-169具有糖基化差异；因为它具有更多的G1F、G2F、唾液酸和高甘露糖含量。进行了进一步的调查，以评估两种产品之间的差异是否会影响PRO-169的疗效和安全性。PRO-169的体外生物活性没有变化；此外，在分析、体外和体内试验中，通过不同的正交方法证明，不应存在细胞毒性或免疫原性问题。这些结果支持将PRO-169转入临床测试，因为预计其在眼科疾病治疗中的临床应用不会出现重大并发症。

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Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab

PRO-169 is an anti-VEGF monoclonal antibody developed by Laboratorios Sophia that shares its sequence with Bevacizumab (BVZ); though, PRO-169 is intended for intravitreal administration. In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169.

PRO-169 had no alteration in its in vitro biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, in vitro and in vivo assays. These results support moving to the clinical testing of PRO-169 since no major complications will be expected with its clinical use for the treatment of ophthalmic diseases.

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.

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