A Mab A Case Study In Bioprocess Development !full! Jun 2026

At Day 8 of the fed-batch culture, Size-Exclusion Chromatography (SEC) shows a spike in high-molecular-weight (HMW) species (aggregates) from 2% to 8%. This is a critical failure if not addressed.

The tech transfer succeeded after three engineering runs, with yield within 95–102% of pilot scale. A Mab A Case Study In Bioprocess Development

: It demonstrates how to use systematic risk assessments (like FMEA) to justify process parameters and ranges. At Day 8 of the fed-batch culture, Size-Exclusion

Lowering the pH during harvest. As the culture ages, CO2 builds up, lowering pH to 6.7. Mab-X has a unique hydrophobic patch in the Fc region that is prone to unfolding at pH <6.8. : It demonstrates how to use systematic risk

: Determining Critical Quality Attributes (CQAs) —such as glycosylation, aggregation, and host cell protein (HCP) levels—that must be controlled to ensure drug performance.

To see the proposed in the study. a-mab-case-study-version.pdf - ISPE