Manufacturing Scale Empirical Testing of Modified Packing Procedure for Agarose Based Compressible Protein A Resin

Multiproduct mammalian cell culture facilities must maintain operational flexibility, minimizing costly equipment upgrades when possible, while accommodating the evolving needs of downstream purification.  High titer monoclonal antibody processes necessitate the implementation of new high capacity Protein A resins as the initial capture step for purification. The column packing requirements for these new resins can present operational challenges.  We recently implemented a high capacity agarose based resin with recommended packing conditions to obtain a stable bed that exceeded current equipment capability.  Full scale testing (120 cm x 20 cm column) was performed and an alternative packing strategy meeting resin requirements within the existing facility constraints, was identified.  The approach taken and the column bed stability assessment performed at scale will be presented.