Surface Activity of a Monoclonal Antibody

The Degradation of Polysorbates 20 and 80 and its Potential Impact on the Stability of Biotherapeutics

“…4 shows surface pressure of polysorbate solutions measured by a modified Du Nuoy method over a concentration range up to 0.05% (w/v) polysorbate for samples initially (t0) and after 12 months. The t0 sample displays a typical sigmoidal behavior for change in surface pressure over concentration for both PS20 and PS80-containing formulations as observed previously (23). The same samples stored for 12 months at 25°C, containing reduced apparent polysorbate concentration (due to increased polysorbate degradation) displayed surface pressure curves with similar characteristics as the initial measurements.…”

“…Surface pressure curves were measured using a modified Du Nouy method on a Kibron (Espoo, Finland) MultiPi WS 1 multichannel tensiometer as previously described (23). The system was calibrated against water with a known surface tension of 72.5 mNm.…”

“…Samples were analyzed for protein aggregation by visual inspection and size exclusion chromatography (SE-HPLC) as described previously (2). Polysorbate quantification was carried out by a fluorescence based assay as described previously (22,23).…”

Key interactions of surfactants in therapeutic protein formulations: A review

“…This is due to the previously mentioned propensity of the polysorbate molecules to associate and orient themselves with the air-liquid interface. This trend of concentration dependent reduction (up to the CMC) of the surface tension remains for polysorbates in the presence of protein solutions, although often altered by the surface activity of the protein itself [25]. A similar study, based on dynamic surface tension, also demonstrated surface tension increases of polysorbate 80 solutions in the presence of protein (HSA); this suggests the lack of surface active molecules present at the air-water interface was attributable to surfactant-protein interactions in solution [85].…”

“…The apparent CMC of a formulated protein solution containing a surfactant may be influenced by other molecules such as excipients, as well as the surface active protein drug itself; wherein the CMC of a surfactant typically tends towards higher concentrations, presumably due to competitive interaction with the protein in solution [25]. Nonionic surfactants are widely used in protein formulations, especially parenteral monoclonal antibody formulations in both liquid and dried (e.g.…”