There are limited published data on bio-physical properties of monoclonal antibodies at the high concentrations and compositions encountered during bioseparations and concentration of IgG type monoclonal antibodies. Here, we report the measurement of viscosity, osmotic pressure and density of b-IgG solutions over ranges of protein and salt concentrations and which span conditions that are likely to be broadly encountered during manufacturing processes for IgG proteins. The compositions examined consisted of b-IgG in citrate buffer at concentrations of 29 to 262 mg/mL, and NaCl from 21-59 mM. A key process parameter in TFF of proteins is osmotic pressure, which is difficult to measure off-line at operational conditions and at high protein concentrations. The modification of a process TFF cassette to enable measurements of internal pressures at operational conditions is described, and the combination of the data with a deterministic model of TFF operation for determining osmotic pressure at process conditions is presented.

Physical property measurements of highly concentrated protein formulations

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