title: Key interactions of surfactants in therapeutic protein formulations: A review.
abstract: Proteins as amphiphilic, surface-active macromolecules, demonstrate substantial interfacial activity, which causes considerable impact on their multifarious applications. A commonly adapted measure to prevent interfacial damage to proteins is the use of nonionic surfactants. Particularly in biotherapeutic formulations, the use of nonionic surfactants is ubiquitous in order to prevent the impact of interfacial stress on drug product stability. The scope of this review is to convey the current understanding of interactions of nonionic surfactants with proteins both at the interface and in solution, with specific focus to their effects on biotherapeutic formulations.
authors.affiliation: Pharmaceutical Development and Supplies, Pharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland; Center for Cellular Imaging and NanoAnalytics, Biozentrum, University of Basel, Basel, Switzerland.
authors.forename: Tarik A
authors.initials: TA
authors.lastname: Khan
authors.affiliation: Pharmaceutical Development and Supplies, Pharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Hanns-Christian
authors.initials: HC
authors.lastname: Mahler
authors.affiliation: Pharmaceutical Development and Supplies, Pharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland. Electronic address: satya_krishna_kishore.ravuri@roche.com.
authors.forename: Ravuri S K
authors.initials: RS
authors.lastname: Kishore
mesh_terms: D001691:Biological Therapy / Q000379:methods; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D011506:Proteins / Q000008:administration & dosage*; D013501:Surface-Active Agents / Q000737:chemistry*
chemical_list: D011506:Proteins; D013501:Surface-Active Agents
keywords: Poloxamer; Polysorbates; Protein formulations; Stabilization; Surfactants