Multi attribute method implementation using a High Resolution Mass Spectrometry platform: From sample preparation to batch analysis.

ABSTRACT: Quality control of biopharmaceuticals such as monoclonal antibodies (mAbs) has been evolving and becoming more challenging as the requirements of the regulatory agencies increase due to the demanding complexity of products under evaluation. Mass Spectrometry (MS)-based methods such as the multi-attribute method (MAM) are being explored to achieve a deeper understanding of the attributes critical for the safety, efficacy, and quality of these products. MAM uses high mass accuracy/high-resolution MS data that enables the direct and simultaneous monitoring of relevant product quality attributes (PQAs, in particular, chemical modifications) in a single workflow, replacing several orthogonal methods, reducing time and costs associated with these assays. Here we describe a MAM implementation pro

SUBMITTER: Carvalho SB 

PROVIDER: S-EPMC8794205 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature