(556f) Comparison of An Existing Scale-Down Membrane Adsorber Device to Ultra Small Membrane Adsorbers for Rapid Screening and Process Development

Membrane adsorbers have potential advantages over standard chromatography resins for the development of downstream purification of monoclonal antibodies, but during early downstream process development the large material requirements to achieve full capacity loading may be prohibitive using current lab scale devices . In addition, typical development methods for a single purification step require numerous runs to identify optimal operating conditions. Rapid approaches to optimize and develop purification processes are essential to meet compressed project timelines while obtaining data that correlate to manufacturing scale devices.

Ultra small membrane adsorber devices were compared to an existing Sartobind Q membrane scale-down device. The ultra small membrane devices tested included a 15-layer device with a membrane volume of 0.15 mL and a 3-layer, 96-well plate format device with a membrane volume of 0.017 mL per well utilizing a robotic liquid handling system. All devices were screened using 2 monoclonal antibodies at various operating conditions and evaluated for host cell protein clearance. Impurity breakthrough on the tested ultra small devices correlated with the existing Sartobind Q membrane scale-down device. By reducing material requirements and experimental times, ultra small membrane adsorbers prove to be a powerful tool for rapid screening and development.