TABLE VII

Mixinga of Various Protein Formulations in Small-Scale Study: Impact on Filter Foulingb and Particle Formation

Protein FormulationFactor to Normalize FiltrationMmax (mL)
Control (Not Mixed)Mixed Using SB1Mixed Using SB2
mAb A1.00>10,00011204
mAb B2.25>1,0004694
mAb C4.82>10,0001759
mAb D6.50>1,0001057
mAb E4.69>10,0009164
Fab A0.97>5,0001158
Fab B1.07>10,000935
BSA1.67>10,000>10,000>3,000
tPA1.11>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.