Multi-Attribute Monitoring & Comprehensive Analysis of mAb CQAs throughout the Manufacturing Process

Poster Authors:

Andrew Duckworth, Luiza Chrojan, Kirsty McManus, Patrick Hoering, Paul Getty and John Allen

Pharmaron l Estuary Commerce Park, Speke, Liverpool, L24 8RB, UK

mAb CQA Significance in Manufacturing

mAb critical quality attributes (CQAs) must be tracked at every manufacturing stage to prevent delayed release testing, complicate regulatory filings, and costly reworks. Unique analytical method development leads to a variety of strategies needed for aggregation, charge variants, glycosylation, oxidation, and deamidation.

Pharmaron’s Biologics team addresses this with a multi-attribute monitoring (MAM) approach that pairs rapid in-process methods with orthogonal characterization techniques, resulting in a holistic CQA coverage from cell line development through DP release and stability.

Multi-Attribute Monitoring

Multi-attribute monitoring condenses multiple CQA readouts into a single high-throughput run. At PEGS Boston 2026, Pharmaron presented data showing how a combination of MAM and single-attribute methods provided a detailed CQA profile across forced degradation conditions. A commercially available IgG1 mAb was stressed under acidic pH (3.5), basic pH (8.5), elevated temperature (50 °C for 7 days) and oxidative conditions (6 mM H₂O₂ for 20 hours). CQAs were then assessed at both upstream (clarified cell culture fluid) and final drug product stages.