プログラム

オーラルセッション

第4日　5月18日（金）　10:20～10:40　C会場（星雲2）

4C-O1-P-1020　　PDF

規制対応LC/MSプラットフォームを用いたモノクローナル抗体のサブユニット、ペプチドレベルにおける重要品質特性のマルチモニタリング

(¹日本ウォーターズ・ ²ウォーターズ)
^o廣瀬賢治¹・ Fang, Jing²・ Ranbaduge, Nilini²・ Shion, Henry²・ Du, Min²・ Yu, Ying²・ Berger, Scott²・ Chen, Weibin²

The extension of mass spectrometry (MS) to late development and QC environments has promised significant advantages for multiplex monitoring critical quality attributes (CQAs) at the molecular level, providing an in-depth understanding of the biotherapeutic production process and facilitating implementation of Quality by Design (QbD) initiatives for upstream and downstream processing, stability, and formulation activities. Here, we demonstrate the applicability of High resolution (HR) MS for multi-attribute monitoring (MAM) at both the peptide and subunit levels, using an HRMS platform capable of operating under the compliance requirements typical to regulated development and QC organizations. Subunit MAM exhibited minimimal sample preparation artifacts, and enabled higher assay throughput, both key advantages in for routine monitoring of domain-specific CQAs. Peptide-map based MAM enables site-specific information and the ability to monitor deamidation and isomerization attributes, but resulted in greater sample preparation complexity, greater data analysis complexity, and longer analysis run times. In this work, we have evaluated and compared these two analytical workflows (Subunit MAM and Peptide Map MAM) to determine the capacity of MS-based methods for monitoring several common classes of biotherapeutic attributes.