A Mab A Case Study In Bioprocess Development

Depth filtration (3.0 µm to 0.2 µm) followed by a 0.1 µm pre-filter. The team also introduces a low-pH hold step (pH 3.7 for 60 minutes) before loading to precipitate some HCPs, which are then removed by a second depth filter.

The final train: . CEX removed aggregates to <0.8%; AEX removed residual DNA (<10 pg/dose) and HCP (<5 ppm). A Mab A Case Study In Bioprocess Development

Humanized IgG1 mAb targeting a cancer antigen. Indication: Solid tumors. Target Dose: 500 mg per patient, every 3 weeks. Annual Demand: 50 kg (clinical → early commercial). Critical Quality Attributes (CQAs): Depth filtration (3