Physical origin of the peak tailing of monoclonal antibodies in size-exclusion chromatography using bio-compatible systems and columns

Gritti, Fabrice; Meyyappan, Sornanathan

doi:10.1007/s00216-023-05119-2

Anal Bioanal Chem

2024

DOI: 10.1007/s00216-023-05119-2

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Physical origin of the peak tailing of monoclonal antibodies in size-exclusion chromatography using bio-compatible systems and columns

Fabrice Gritti,

Sornanathan Meyyappan

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Cited by 2 publications

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Assessing the Manufacturability and Critical Quality Attribute Profiles of Anti-IL-8 Immunoglobulin G Mutant Variants

Armstrong,

Burley,

Lewis

et al. 2024

Mol. Pharmaceutics

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Early-phase manufacturability assessment of highconcentration therapeutic monoclonal antibodies (mAbs) involves screening of process-related risks impacting their translation into the clinic. Manufacturing a mAb at scale relies on cost-effective and robust approaches to derisk manufacturability parameters, such as viscosity, conformational stability, aggregation, and process-related impurities. Using a panel of model anti-IL-8 IgG1 mutants, we investigate upstream and downstream processability, phase behavior, and process-related impurities. We correlate trends in the biophysical properties of mAbs with their cell growth, expression, filtration flux, solubility, and post-translational modifications. We find significant trends in increased relative free light chain expression with heavy chain mutants and detect a requirement for adjusted operation pH for cation exchange polishing steps with charge-altering variants. Moreover, trends between phase stability and high-concentration viscosity were observed. We also investigated unique correlations between increased glycosylation and biophysical behavior. Further in-depth analysis and modeling are required to elucidate the impact of the mAb sequence on the metabolism of the expression system, solubility limits, and alternative gelation models as future directions.

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Assessing the Manufacturability and Critical Quality Attribute Profiles of Anti-IL-8 Immunoglobulin G Mutant Variants

Armstrong,

Burley,

Lewis

et al. 2024

Mol. Pharmaceutics

View full text Add to dashboard Cite

show abstract

Analysis of Therapeutic Monoclonal Antibodies Using a Platform Size Exclusion-HPLC Method

Sutton,

Truong,

Han

et al. 2024

LCGC Int.

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In biotherapeutics manufacturing, controlling size variants of therapeutic monoclonal antibodies (mAbs) is critical for ensuring product quality. Size-exclusion chromatography (SEC) is a leading method for analyzing size variants by separating high molecular weight and low molecular weight species from the monomer based on their hydrodynamic radius. We present a platform size exclusion-HPLC (SE–HPLC) method for analyzing a wide range of mAbs of different subclasses, demonstrating its feasibility through rigorous validation and evaluation. Our study highlights the method’s reproducibility, robustness, and ability to distinguish differences in size variants.

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Physical origin of the peak tailing of monoclonal antibodies in size-exclusion chromatography using bio-compatible systems and columns

Cited by 2 publications

References 41 publications

Assessing the Manufacturability and Critical Quality Attribute Profiles of Anti-IL-8 Immunoglobulin G Mutant Variants

Assessing the Manufacturability and Critical Quality Attribute Profiles of Anti-IL-8 Immunoglobulin G Mutant Variants

Analysis of Therapeutic Monoclonal Antibodies Using a Platform Size Exclusion-HPLC Method

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