Access our recent poster from WADC entitled: Development of an ADC Process with Single Use Membrane Technology
Abstract:
Membrane chromatography is routinely used to remove host cell proteins, viral particles, and aggregates during antibody downstream processing. The application of membrane chromatography to the field of antibody-drug conjugates (ADCs) has been applied in a limited capacity and in only
specialized scenarios.
Here, we utilized the characteristics of the membrane adsorbers, Sartobind® S and Phenyl, for aggregate and payload clearance while polishing the ADC in a single chromatographic run. The Sartobind® S membrane was used in the removal of excess payload while the Sartobind® Phenyl was used to polish the ADC by clearance of unwanted DAR species and aggregates. The Sartobind® S membrane reproducibly achieved log-fold clearance of free payload with a ten membrane volume wash. Application of the Sartobind® Phenyl decreased aggregates and higher DAR species while increasing DAR homogeneity. The Sartobind® S and Phenyl membranes were placed in tandem to simplify the process in a single chromatographic run. With the optimized binding, washing and elution conditions, the tandem membrane approach was performed in a shorter timescale with minimum solvent consumption with high yield. The application of the tandem membrane chromatography system presents a novel and efficient purification scheme that can be realized during ADC manufacturing
