title: Weak partitioning chromatography for anion exchange purification of monoclonal antibodies.
abstract: Weak partitioning chromatography (WPC) is an isocratic chromatographic protein separation method performed under mobile phase conditions where a significant amount of the product protein binds to the resin, well in excess of typical flowthrough operations. The more stringent load and wash conditions lead to improved removal of more tightly binding impurities, although at the cost of a reduction in step yield. The step yield can be restored by extending the column load and incorporating a short wash at the end of the load stage. The use of WPC with anion exchange resins enables a two-column cGMP purification platform to be used for many different mAbs. The operating window for WPC can be easily established using high throughput batch-binding screens. Under conditions that favor very strong product binding, competitive effects from product binding can give rise to a reduction in column loading capacity. Robust performance of WPC anion exchange chromatography has been demonstrated in multiple cGMP mAb purification processes. Excellent clearance of host cell proteins, leached Protein A, DNA, high molecular weight species, and model virus has been achieved.
authors: Purification Process Development, Wyeth BioPharma, 1 Burtt Road, Andover, Massachusetts 01810, USA.
authors: Brian D
authors: BD
authors: Kelley
authors: Scott A
authors: SA
authors: Tobler
authors: Paul
authors: P
authors: Brown
authors: Jonathan L
authors: JL
authors: Coffman
authors: Ranga
authors: R
authors: Godavarti
authors: Timothy
authors: T
authors: Iskra
authors: Mary
authors: M
authors: Switzer
authors: Suresh
authors: S
authors: Vunnum
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000302:isolation & purification*; D016466:CHO Cells; D002852:Chromatography, Ion Exchange / Q000379:methods; D006224:Cricetinae; D003412:Cricetulus
chemical_list: D000911:Antibodies, Monoclonal