A Mab A Case Study In Bioprocess Development |top| Jun 2026

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

This comprehensive document was created as a collaborative industry effort to illustrate how Quality by Design (QbD) Depth filtration (3