title: A straightforward methodology for designing continuous monoclonal antibody capture multi-column chromatography processes.
abstract: A simple process development strategy for continuous capture multi-column chromatography (MCC) is described. The approach involves a few single column breakthrough experiments, based on several simplifying observations that enable users to rapidly convert batch processes into well-designed multi-column processes. The method was validated using a BioSMB(®) (Pall Life Sciences) lab scale multi-column system and a mAb capture process employing Protein A resin. The approach enables users to optimize MCC processes based on their internal preferences and constraints without requiring any mathematical modeling expertise.
authors.affiliation: Pall Life Sciences, Westborough, MA, USA.
authors.forename: Xhorxhi
authors.initials: X
authors.lastname: Gjoka
authors.affiliation: Pall Life Sciences, Westborough, MA, USA.
authors.forename: Karl
authors.initials: K
authors.lastname: Rogler
authors.affiliation: Pall Life Sciences, Westborough, MA, USA.
authors.forename: Richard Alexander
authors.initials: RA
authors.lastname: Martino
authors.affiliation: Pall Life Sciences, Westborough, MA, USA.
authors.forename: Rene
authors.initials: R
authors.lastname: Gantier
authors.affiliation: Pall Life Sciences, Westborough, MA, USA. Electronic address: Mark_Schofield@Pall.com.
authors.forename: Mark
authors.initials: M
authors.lastname: Schofield
mesh_terms: D000911:Antibodies, Monoclonal / Q000737:chemistry*; D002846:Chromatography, Affinity / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D008962:Models, Theoretical; D013205:Staphylococcal Protein A / Q000737:chemistry*
chemical_list: D000911:Antibodies, Monoclonal; D013205:Staphylococcal Protein A
keywords: BioSMB; Continuous bioprocess; Multi-column chromatography