title: Impact of antibody aggregation on a flowthrough anion-exchange membrane process.
abstract: The impact of typical anion-exchange flowthrough conditions on the IgG mass loading of an anion-exchange membrane scale-down unit (Mustang Q coin) was investigated. High performance size-exclusion chromatography and multiangle laser light scattering results suggested the presence of a small fraction of IgG aggregates with average radius >100 nm under anion-exchange flowthrough conditions. The small filtration area presented by the 0.35 mL membrane volume Mustang Q coin limited the membrane throughput due to fouling from the aggregates at higher antibody loading. Data in this report indicated that a 0.2 μm hybrid polyethersulfone and polyvinylidene fluoride membrane in-line prefilter with a minimum filtration area of 20 sq cm alleviated the Mustang Q coin fouling. The combined cake filtration and intermediate blocking model was proposed as the most likely membrane pore blocking mechanism. Increasing the filtration area in the in-line prefilter resulted in higher IgG mass throughput. Thus, using an appropriately sized in-line prefilter could provide more robust antibody throughput performance on scale-down membrane anion-exchange units.
authors.affiliation: Pall Life Sciences, 8780 Ely Road, Pensacola, FL 32514, USA. ajay_lajmi@pall.com
authors.forename: Ajay R
authors.initials: AR
authors.lastname: Lajmi
authors.forename: Samuel
authors.initials: S
authors.lastname: Nochumson
authors.forename: Aym
authors.initials: A
authors.lastname: Berges
mesh_terms: D000838:Anions / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D002852:Chromatography, Ion Exchange; D007074:Immunoglobulin G / Q000737:chemistry*; D007834:Lasers; D008567:Membranes, Artificial; D010316:Particle Size; D012542:Scattering, Radiation; D013499:Surface Properties
chemical_list: D000838:Anions; D007074:Immunoglobulin G; D008567:Membranes, Artificial