As one of the main categories of biopharmaceuticals, monoclonal antibodies (mAbs) are effective against a wide range of diseases, from cancer and asthma to heart disease and infectious disease. During the manufacturing, storage, transport, and administration of mAbs, they are exposed to multiple sources of biophysical and biochemical stress, which results in aggregation, fragmentation, and chemical modifications. In light of the increase in complexity of products under evaluation, the regulatory agencies' requirements for quality control on biopharmaceuticals have evolved and become more challenging. A mass spectrometry (MS) based multi-attribute monitoring (MAM) workflow was implemented using NIST mAb reference material and Avastin (Bevacizumab) mAb samples. This MAM workflow has been successfully applied for comprehensive characterization of glycosylation profiles and different types of modifications. Furthermore, an automated online digestion using the Perfinity HPLC and a sequential reverse phase (RP) separation protocol has been developed using NIST mAb for peptide mapping.
Learning Objectives:
Monoclonal antibodies (mAbs) are effective against many different diseases. During this presentation, attendees will learn which analytical techniques would be the most effective and reliable for QA/QC and manufacturing.
The concept of multi-attribute monitoring (MAM), which provides a better understanding of the critical attributes that affect the safety, efficacy, and quality of biologics, will be presented in this presentation.
An automated online digestion using the Perfinity HPLC and a sequential reverse phase (RP) separation protocol using NIST mAb reference material for peptide mapping will be presented as MAM too.
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