title: Performance comparison of protein A affinity resins for the purification of monoclonal antibodies.
abstract: During the selection of protein A affinity resin for the purification of monoclonal antibodies, dynamic binding capacity (Q(dyn10%)), volumetric production rate (Pr(vol)) and 'process robustness' are essential parameters to be evaluated. In this article, empirical mathematical models describe these parameters as a function of antibody concentration in load (C0), load flow rate (u(load)) and bed height (L). These models allow us to select optimal process conditions for each of the evaluated protein A affinity resins. C0, u(load) and L largely affect dynamic binding capacity (Q(dyn10%)) and volumetric production rate (Pr(vol)). Maximum Q(dyn10%) is generally obtained at high C0 and at low u(load). Maximum Pr(vol) is obtained at high C0 and at lowest L, run at high u(load). All evaluated resins have a relatively high robustness against variations in C0. |DeltaQ(dyn10%)/deltaC0| ranges from 0.0 to 7.8. It is clear that Q(dyn10%), Pr(vol) and 'process robustness' cannot be maximized all at the same time. Furthermore, some other aspects like IgG recovery, protein A leaching, easiness to pack, easiness to clean, number of re-uses and cost of production might be important to be taken into the equation. Certain evaluation parameters may be more important than others, depending on the specific situation. Therefore, a case-by-case evaluation is recommended.
authors.affiliation: Technology Department, Genzyme, Cipalstraat 8, Geel, Belgium. koenraad.swinnen@genzyme.com
authors.forename: K
authors.initials: K
authors.lastname: Swinnen
authors.forename: A
authors.initials: A
authors.lastname: Krul
authors.forename: I
authors.initials: I
authors.lastname: Van Goidsenhoven
authors.forename: N
authors.initials: N
authors.lastname: Van Tichelt
authors.forename: A
authors.initials: A
authors.lastname: Roosen
authors.forename: K
authors.initials: K
authors.lastname: Van Houdt
mesh_terms: D000465:Algorithms; D000818:Animals; D000911:Antibodies, Monoclonal / Q000096:biosynthesis / Q000737:chemistry / Q000302:isolation & purification*; D002846:Chromatography, Affinity / Q000379:methods*; D004591:Electrophoresis, Polyacrylamide Gel; D006801:Humans; D006825:Hybridomas; D007074:Immunoglobulin G / Q000096:biosynthesis / Q000737:chemistry / Q000302:isolation & purification; D051379:Mice; D015203:Reproducibility of Results; D013205:Staphylococcal Protein A / Q000737:chemistry*
chemical_list: D000911:Antibodies, Monoclonal; D007074:Immunoglobulin G; D013205:Staphylococcal Protein A