721b

Semi-Continuous Processing In the Pilot Scale Purification of Monoclonal Antibodies

Beth McCooey, Alison Chow, Craig Emery, and Brian Kluck. Genentech, Inc, 1 Antibody Way, Oceanside, CA 92056

Semi-continuous downstream processing of monoclonal antibodies can be achieved by the integration of two chromatography skids, allowing two columns, or a membrane and a column, to be run without an intermediate hold step. To accomplish this, dilution and pH adjustment are performed in-line prior to the second unit operation. Implementation of semi-continuous processing in manufacturing facilities will allow for significant savings by reducing processing time, product hold tanks, and cleaning. An evaluation of semi-continuous processing was performed at pilot scale with the intent of scaling the process up to clinical and manufacturing scales. To ensure consistent process performance, pH, conductivity, and UV absorbance were monitored. Our results demonstrate that product quality, impurity clearance, and yield are comparable to standard processing.