A Mab A Case Study In Bioprocess Development <High-Quality ✭>

Using tangential flow filtration (TFF) with 30 kDa cassettes, the team concentrates Mab-X from 2 mg/mL to 120 mg/mL. Viscosity becomes the enemy. At 100 mg/mL, viscosity reaches 25 cP, causing high pump shear and membrane fouling.

Innovation: The team adjusts the buffer to 10 mM histidine (pH 6.0) with 150 mM arginine and 5% trehalose. This combination reduces viscosity to 8 cP at 120 mg/mL, allowing efficient TFF. A Mab A Case Study In Bioprocess Development

The 2,000L harvest contained A Mab at 6.8 g/L, plus host cell proteins (HCPs), DNA, and cell debris. The train: Using tangential flow filtration (TFF) with 30 kDa

No centrifugation used because A Mab’s small aggregates (5%) were shear-sensitive. Cell banking and characterization: master cell bank (MCB)