Stability-Indicating Methods For MAbs

Pharmaron poster on an integrated multi-attribute toolkit with stability-indicating methods for end-to-end monitoring of mAb CQAs, PDF download button

Poster Authors:

Andrew Duckworth, Luiza Chrojan, Kirsty McManus, Patrick Hoering, Paul Getty, Lucy Ballantine, John Allen and Christopher Sadler

Pharmaron, Liverpool

Stability-Indicating Methods

As biologics advance through development and manufacturing, maintaining product quality requires a thorough understanding of critical quality attributes (CQAs). From cell line development through drug product release, robust analytical strategies are essential for detecting changes that can impact safety, efficacy, stability, and manufacturability.

This scientific poster from Festival of Biologics showcases how an integrated suite of orthogonal and multi-attribute analytical methods can provide comprehensive monitoring of monoclonal antibody quality throughout the product lifecycle.

Download the poster to explore how advanced analytical platforms can:

Monitor mAb CQAs across development, process characterization, stability studies, and GMP release testing
Detect changes in aggregation, charge variants, glycosylation, oxidation, deamidation, molecular mass, and biological activity
Generate rapid in-process insights during cell line development and upstream processing using Protein A-MS and multi-attribute monitoring
Assess product potency through SPR and evaluate the impact of stress-induced degradation on target binding
Characterize degradation pathways using SEC-MALS, SCX-UPLC-MS, cIEF, intact mass analysis, and peptide mapping

Capabilities

Knowledge Center

Analytical Services

Biologics Analytical Services for CMC Development

Characterization

mAb CQA Analysis Across the Manufacturing Process

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What is in the poster?

The poster covers all the supporting data: the full analytical portfolio, Protein A-MS titer and glycan traces, SEC-MALS profiles, charge variant overlays, peptide map results for oxidation, and deamidation and the SPR binding comparison.

Download the Full Scientific Poster

Gain a detailed understanding of how integrated multi-attribute and orthogonal analytical technologies can support comprehensive mAb characterization from early development through commercial manufacture.

Three scientists in lab coats and masks collaborate in a high-tech lab, utilizing advanced bioanalysis instruments like LC-MS for research services.

Discover analytical strategies that can help accelerate biologics development

Download the poster

References

1. FDA. Q5C Stability Testing of Biotechnological/Biological Products (ICH).

2. FDA. Q6B Specifications for Biotechnological/Biological Products (ICH).

3. Nowak C, et al. Forced degradation of recombinant mAbs: A practical guide. MAbs. 2017;9(8):1217-1230.

4. Rogers RS, et al. Quantitative MS multi-attribute method for biologics. MAbs. 2015;7(5):881-890.

5. EMA. ICH Q5C Stability testing of biotechnological/biological products.