title: Adsorption behavior of a surfactant and a monoclonal antibody to sterilizing-grade filters.
abstract: Formulations of therapeutic proteins usually contain a surfactant such as polysorbate 80 to protect them against interfacial stresses. Since surfactants may interact with surfaces, the aim of the present work was to study the adsorption behavior of low concentrations of polysorbate 80 and of a monoclonal antibody during sterile filtration. Lab-scale tests were performed to study the adsorption behavior of a monoclonal antibody to different filter materials (PVDF, PES, CA, and Nylon) from different suppliers. Subsequently, protein and polysorbate 80 adsorption were tested in manufacturing scale experiments. It was found that the extent of protein adsorption differed with filter materials, but also with different suppliers. Prominently, Nylon filters showed the highest degree of protein adsorption. In manufacturing-scale filtration experiments, significant adsorption of polysorbate 80 to sterilizing-grade filters was found. Thus, the adsorption of both protein and polysorbate to filters should be taken into consideration in the formulation and manufacturing process and assessed on a case-by-case basis depending on the manufacturing process set-up.
authors.affiliation: Merck KGaA, Pharmaceutical Development, Darmstadt, Germany. hanns-christian.mahler@roche.com
authors.forename: Hanns-Christian
authors.initials: HC
authors.lastname: Mahler
authors.forename: Franziska
authors.initials: F
authors.lastname: Huber
authors.forename: Ravuri S K
authors.initials: RS
authors.lastname: Kishore
authors.forename: Jürgen
authors.initials: J
authors.lastname: Reindl
authors.forename: Peter
authors.initials: P
authors.lastname: Rückert
authors.forename: Robert
authors.initials: R
authors.lastname: Müller
mesh_terms: D000327:Adsorption; D000911:Antibodies, Monoclonal / Q000302:isolation & purification*; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation; D005374:Filtration / Q000295:instrumentation; D008074:Lipoproteins; D009757:Nylons; D011136:Polysorbates; D011506:Proteins; D013501:Surface-Active Agents
chemical_list: D000911:Antibodies, Monoclonal; D008074:Lipoproteins; D009757:Nylons; D011136:Polysorbates; D011506:Proteins; D013501:Surface-Active Agents