A Mab A Case Study In Bioprocess Development May 2026

Having developed a robust process at 50 L and 200 L pilot scales, the team transfers to a 10,000 L commercial facility. The case study highlights three common pitfalls:

The production process included a dedicated Low pH hold (pH 3.5 for 60 min) after elution. A Mab A Case Study In Bioprocess Development

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. Having developed a robust process at 50 L

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. the team transfers to a 10