{"id":13927,"date":"2023-12-08T10:44:24","date_gmt":"2023-12-08T01:44:24","guid":{"rendered":"https:\/\/www.emukk.com\/WP\/?p=13927"},"modified":"2024-09-18T07:15:01","modified_gmt":"2024-09-17T22:15:01","slug":"fda-announced-rapid-glycan-profiling-with-a-9-lectin-microarray-for-therapeutic-igg1-monoclonal-antibodies","status":"publish","type":"post","link":"https:\/\/www.emukk.com\/WP\/en\/fda-announced-rapid-glycan-profiling-with-a-9-lectin-microarray-for-therapeutic-igg1-monoclonal-antibodies\/","title":{"rendered":"FDA announced High-throughput Glycan Profiling Analysis with a 9-Lectin Microarray for Therapeutic IgG1 mAbs"},"content":{"rendered":"

To evaluate glycan epitopes of therapeutic IgG1 mAbs, FDA has developed a new lectin microarray with 9 kinds of lectins, and has demonstrated its effectiveness for high-throughput glycan profiling analysis using GlycoStation Reader 2300 (GSR2300) .<\/a>
\n2023 FDA Science Forum<\/a>
\nAccepted paper\uff1aA tailored lectin microarray for rapid glycan profiling of therapeutic monoclonal antibodies<\/a>
\nFDA Homepage Discription<\/a>
\nAccepted paper\uff1aLectin-Based Fluorescent Comparison of Glycan Profile\u2014FDA Validation to Expedite Approval of Biosimilars<\/a><\/p>\n

The new lectin microarray (IgG1-mAb-LecChip) developed by FDA immobilizes 9 kinds of lectins: rPhosL, rOTH3, RCA120, rMan2, MAL_I, rPSL1a, PHAE, rMOA, and PHEL, and uses a standard 14 wells LecChip format<\/a>.
\nGlycan analysis of IgG1 mAbs can be performed using lectin microarrays without creaving glycans, making it possible to perform high-throughput glycan profiling analysis from intact IgG1.
\nFDA has recommended pharmaceutical companies to use IgG1-mAb-LecChip and GlycoStation to facilitate high-throughput glycan profiling analysis when developing IgG1 mAbs to assess batch-to-batch or biosimilar-to-innovator glycan epitopes.<\/p>\n

The figure below shows how IgG1-mAb-LecChip, which was optimized for IgG1 glycan analysis, was developed using GlycoStation and LecChip (n=74 library).<\/p>\n

\"\"<\/a><\/p>\n

As an example of showing the effectiveness of this technology, the figure below shows the result of evaluating the differences in glycosylation between Infliximab and its biosimilar using IgG1-mAB-LecChip and GSR2300. It can be clearly seen that there are significant differences in the abundance of High Mannose structure, sialic acid modification, and triantennary N-glycans.<\/p>\n

\"\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

To evaluate glycan epitopes of therapeutic IgG1 mAbs, FDA has developed a new lectin microarray with 9 kinds o<\/p><\/div>\n

\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-13927","post","type-post","status-publish","format-standard","hentry","category-technology-en"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/posts\/13927","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/comments?post=13927"}],"version-history":[{"count":17,"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/posts\/13927\/revisions"}],"predecessor-version":[{"id":13981,"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/posts\/13927\/revisions\/13981"}],"wp:attachment":[{"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/media?parent=13927"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/categories?post=13927"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.emukk.com\/WP\/wp-json\/wp\/v2\/tags?post=13927"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}