ポスター発表
- 第2日 5月16日（火） P会場（ホワイエ，会議室1004-1007）
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2P-48 PDF
新しいベンチトップQTofによるバイオシミラーの同等性評価のためのワークフロー
With the increasing prevalence of biosimilar monoclonal antibodies (mAbs) in the drug development landscape, the need for robust liquid chromatography-mass spectrometry (LC-MS) instruments and streamlined characterization workflows is critical. In this paper we describe modifications to a commercial QTof MS with UPLC™ that are preventing adsorption treatment to extend the dynamic range, improve the robustness and sensitivity, particularly for thermally labile compounds. Then, samples of Remicade® (innovator) and three biosimilars (Inflectra®, Avsola®, and Renflexis®) were analyzed at intact and subunit levels via denaturing RPLC-MS and native IEX-UV-MS. The results from RPLC-MS and IEX-UV-MS are in agreement regarding C-terminal lysine variants and Nglycoform distribution. For C-terminal lysine variants, both Remicade and Inflectra were observed with ~48% retained, Avsola was observed with ~35%, and Renflexis with only ~5%. Overall N-glycoform distribution observed with intact RPLC-MS and intact/subunit IEX-UV-MS are comparable for each biosimilar. This paper was demonstrated the improved bench-top LC- QTof with compliance-ready software provide an effective workflow for detailed orthogonal characterization and comparability assessment of mAb drug products and biosimilars.