Study of Protein Adsorption During Sterile Filtration of Protein Formulations by ILC

Protein adsorption is usually regarded as the main reason for filter fouling in sterile filtration of protein formulations. To achieve a better insight into this phenomenon, protein adsorption was studied during filtration of stabilized bovine serum albumin (BSA) and γ‐globulin formulations through 0.2‐µm microfilter membranes by inverse liquid chromatography (ILC). Adsorption processes can be studied with this method by measurement of breakthrough curves. The change of the concentration in the fluid phase is measured with high accuracy by an inline UV‐detector. Adsorption of bovine serum albumin and γ‐globulin to sterile filter membranes is examined with means of liquid chromatography. Breakthrough curves are evaluated and the impact of different membrane materials, filtration flow rate, protein concentration and surfactant concentration (polysorbate 80) are examined.