A Mab A Case Study In Bioprocess Development -
| Challenge | Finding | Solution | |-----------|---------|----------| | (pilot scale) | Shear from peristaltic pump in harvest line | Switch to low-shear diaphragm pump | | Protein A carryover | Leakage ~150 ppm | Add intermediate wash (1 M NaCl + 0.1% Triton) → reduced to 25 ppm | | Aggregate formation during viral inactivation | pH 3.5 for 60 min → 2% aggregates | Reduce hold time to 45 min, add 0.1% PS80 | | UF/DF flux drop | Concentration polarization | Increase crossflow, use 30 kDa Hydrosart membrane |
and bioreactor pH levels, the team shifted the metabolic profile of the CHO (Chinese Hamster Ovary) cells, reducing initial impurity formation. Downstream Innovation: A Mab A Case Study In Bioprocess Development
Humanized IgG1 (pI 8.2), expressed in CHO-K1 cells. The Challenge: High aggregate formation (>15%) and low viral clearance capability during Protein A capture. The team adjusts the buffer to 10 mM histidine (pH 6
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. allowing efficient TFF.
| Challenge | Finding | Solution | |-----------|---------|----------| | (pilot scale) | Shear from peristaltic pump in harvest line | Switch to low-shear diaphragm pump | | Protein A carryover | Leakage ~150 ppm | Add intermediate wash (1 M NaCl + 0.1% Triton) → reduced to 25 ppm | | Aggregate formation during viral inactivation | pH 3.5 for 60 min → 2% aggregates | Reduce hold time to 45 min, add 0.1% PS80 | | UF/DF flux drop | Concentration polarization | Increase crossflow, use 30 kDa Hydrosart membrane |
and bioreactor pH levels, the team shifted the metabolic profile of the CHO (Chinese Hamster Ovary) cells, reducing initial impurity formation. Downstream Innovation:
Humanized IgG1 (pI 8.2), expressed in CHO-K1 cells. The Challenge: High aggregate formation (>15%) and low viral clearance capability during Protein A capture.
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.
