{"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

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