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
{"title":"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。","authors":"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","doi":"10.1016/j.biologicals.2023.101711","DOIUrl":null,"url":null,"abstract":"<div><p>PRO-169 is an <em>anti</em>-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.</p><p>PRO-169 had no alteration in its <em>in vitro</em> biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, <em>in vitro</em> and <em>in vivo</em> 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.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"84 ","pages":"Article 101711"},"PeriodicalIF":1.5000,"publicationDate":"2023-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab\",\"authors\":\"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\",\"doi\":\"10.1016/j.biologicals.2023.101711\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>PRO-169 is an <em>anti</em>-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.</p><p>PRO-169 had no alteration in its <em>in vitro</em> biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, <em>in vitro</em> and <em>in vivo</em> 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.</p></div>\",\"PeriodicalId\":55369,\"journal\":{\"name\":\"Biologicals\",\"volume\":\"84 \",\"pages\":\"Article 101711\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2023-09-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biologicals\",\"FirstCategoryId\":\"99\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1045105623000490\",\"RegionNum\":4,\"RegionCategory\":\"生物学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"BIOCHEMICAL RESEARCH METHODS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biologicals","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1045105623000490","RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
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.
期刊介绍：
Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.
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