Qualification of a Small-Scale Chromatography Model for Viral Clearance and Process Characterization

The objective of this assessment is to evaluate the feasibility of utilizing pre-packed chromatography columns as a valid small-scale model of a manufacturing-scale process for viral clearance evaluation and process characterization. The assessment was evaluated as a collaboration between KBI Biopharma (Durham, NC) and Repligen Corporation (Waltham, MA).

As chromatographic purification has become a prominent tool in downstream manufacturing of monoclonal antibodies and monoclonal antibody derivatives, viral clearance validation has become a pivotal study for any biotherapeutic entering the market.

In this study we use OPUS^® ValiChrom^® Pre-packed Chromatography Columns to execute a scale-down model in the viral clearance spiking studies for a clinically relevant monoclonal antibody purification process.