High Performance Size Exclusion Chromatography and High-Throughput Dynamic Light Scattering as Orthogonal Methods to Screen for Aggregation and Stability of Monoclonal Antibody Drug Products

The presence of aggregates in monoclonal antibody (mAb) drug product (DP) formulations can present product quality challenges. Here we show that use of High Performance Size Exclusion Chromatography (HP-SEC), in conjunction with high-throughput dynamic light scattering (HT-DLS) analyses of mAb DPs c...

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Bibliographic Details
Published in:	Journal of pharmaceutical sciences 2020-11, Vol.109 (11), p.3330-3339
Main Authors:	Bhirde, Ashwinkumar, Chikkaveeraiah, Bhaskara Vijaya, Venna, Ramesh, Carley, Rachel, Brorson, Kurt, Agarabi, Cyrus
Format:	Article
Language:	English
Subjects:	Aggregates Dynamic light scattering High throughput analysis Monoclonal antibody Size exclusion chromatography
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