Mixinga of Various Protein Formulations in Small-Scale Study: Impact on Filter Foulingb and Particle Formation
Protein Formulation | Factor to Normalize Filtration | Mmax (mL) | ||
---|---|---|---|---|
Control (Not Mixed) | Mixed Using SB1 | Mixed Using SB2 | ||
mAb A | 1.00 | >10,000 | 11 | 204 |
mAb B | 2.25 | >1,000 | 46 | 94 |
mAb C | 4.82 | >10,000 | 17 | 59 |
mAb D | 6.50 | >1,000 | 10 | 57 |
mAb E | 4.69 | >10,000 | 9 | 164 |
Fab A | 0.97 | >5,000 | 11 | 58 |
Fab B | 1.07 | >10,000 | 9 | 35 |
BSA | 1.67 | >10,000 | >10,000 | >3,000 |
tPA | 1.11 | >10,000 | >5,000 | >10,000 |
BSA, bovine serum albumin; Fab, fragment antigen binding protein; mAb, monoclonal antibody; tPA, tissue plasminogen activator.
↵a Mixed for 2 h at 180 rpm using stir bar SB1 (standard stir bar) or SB2 (stir bar with ring).
↵b Based on the Mmax model and using a 0.65 cm2 syringe filter with 0.22 μm pore size.