ポスター発表
- 第3日 5月21日（金） P1会場（Zoom）
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3P-22 PDF
高分解能質量分析を用いた抗体医薬品に対するMulti Attribute Method（MAM）の適応
Multi Attribute Method (MAM) was proposed as a new quality evaluation concept for biotherapeutics especially monoclonal antibody (mAb). MAM has attracted attention since it can observe multiple post translation modifications (PTMs) as quality attributes by one method and it is intended to use for product release or stability testing. Peptide map-based MAM is often used to evaluate the level of PTMs due to its high sensitivity and robust process. After digesting samples enzymatically, PTMs in the sample are detected using HRMS with HPLC and the level of each PTM in the sample is calculated from MS intensity of unmodified peptide and modified peptide. We compared the level of quality attributes from general chromatography and electrophoresis base methods and peptide map-based MAM with HRMS. From our data, it was revealed that trends of PTM level from MAM were quite comparable with their associated quality attribute from chromatography method (hydrophilic interaction liquid chromatography) and electrophoresis (CE-SDS and imaged capillary isoelectric focusing). This data may be an example to reveal the usefulness of MAM. In this session, we discuss the possibility of replacement MAM with general methods for evaluation mAb.