Capacity, productivity and cost of operation characterization of a novel high performance protein A chromatography media

BIOT 284

Jim Neville, jim_neville@millipore.com1, Chen Wang2, Bala Raghunath1, Chase Duclos-Orsello3, Alejandro Becerra-Arteaga1, and Fred Mann4. (1) BioProcess Engineering Group, Millipore Corporation, 900 Middlesex Turnpike, Billerica, MA 01821, (2) Chromatography Product Development, BioProcess Research and Development, Millipore Corporation, 80 Ashby Road, Bedford, MA 01730, (3) BioProcess Applications Development Group, Millipore Corporation, Molsheim, France, (4) Technical Marketing, Millipore Corporation, Medomsley Road, Consett, United Kingdom
Abstract:

In order to meet the Biotechnology Industry's need to increase the throughput and improve the economics of downstream MAb purification, significant efforts have been made to enhance protein A chromatography media performance via optimization of binding capacity and flow permeability. Often these two attributes cannot be maximized simultaneously. We report on a recently developed new protein A media which exhibits the most competitive MAb binding and flow performance amongst various commercial resins. For MAb purification, this is a game changing MAb capture technology that helps remove current downstream process and plant constraints.

In this presentation, both theoretical studies and experimentally measured performance data are utilized to display small and large scale perspectives for an end user implementation.

The analyses demonstrate that, relative to various existing commercial counterparts, this new media can provide the highest productivity in a wider operating process window, together with additional operating flexibility under various processing constraints; overall providing the most cost effective protein A media for MAb capture processing.