Adsorption Behavior of a Surfactant and a Monoclonal Antibody to Sterilizing-Grade Filters

Key interactions of surfactants in therapeutic protein formulations: A review

“…Recently, it has been proposed that trace amounts of host cell protein contaminants, in the form of lipases, may further compromise the stability of polysorbates [55]. Additionally, polysorbates are also known to adsorb strongly to materials contacted during processing, like filters and tubing [48].…”

“…Surfactants are effective against various stresses such as agitation by shaking or stirring (air/water interfaces) [7,8,36,37], freezing and thawing (ice/water interfaces), and drying stresses that can occur during lyophilization [38,39]. [23,[40][41][42][43][44] and freeze-thaw stress [23,29,31,41,[45][46][47], but also inhibit adsorption to various surfaces such as sterilization filters and primary packaging [40,48]. Various reports on polysorbate 20 describe the prevention of aggregation against mechanical stress for various types of proteins, including porcine growth hormone [49], recombinant human growth hormone (rHGH) [9] and recombinant human factor XIII [50].…”

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

“…Only those peaks not observable in the control sample were considered for analysis and structure identification. This was of high importance, since it is known that surfactants like polysorbates can adsorb to various surfaces including filters (24) Nuclear Magnetic Resonance (NMR)…”

Effect of Polysorbate 80 Concentration on Thermal and Photostability of a Monoclonal Antibody

“…The potential for intermolecular protein-protein interaction and therefore an increased probability of aggregation is seen at air-water interface where proteins orient themselves to expose hydrophobic regions in order to increase their interaction with the surface (2,3). Polysorbate 80 is widely used in protein formulations to prevent agitation-induced aggregation because of its effectiveness at low concentrations, relative low toxicity, and ability to not only inhibit protein surface adsorption and aggregation under various processing conditions but also act as a stabilizer against protein aggregation (4)(5)(6). Although nonionic surfactants like Polysorbates 80 and 20 are used extensively, mechanisms by which they provide stabilizing effects are only fairly understood (7).…”