Cellulose is well-known as a natural raw material that has mechanical strength, lower nonspecific adsorption, and good biocompatibility. Additionally, cellulose particles have unique pore-size characteristics appropriate for the chromatography of biopharmaceuticals. Mixed-mode chromatography resins are well known to have unique selectivity differences from traditional IEX or HIC resins. Cellufine™ MAX IB, a novel cellulose-based mixed-mode resin, has polyallyl amine partially modified with butyl groups ligand (Figure 1). The resin is used in flow-through mode after a protein A step in monoclonal antibody (MAb) purification. Superior performance of impurities removal from MAbs with this resin can provide two-step MAb purification.

Host-Cell Protein (HCP) Removal with Cellufine™ MAX IB and Polymer-Modified Q AEX After ProA Step: Cellufine™ MAX IB resin exhibits a salt-tolerance property derived from polyamine ligand. In general, high ionic strength decreases adsorption performance of ion-exchange (IEX) resin. Residual Chinese hamster ovary (CHO) HCP levels were measured to evaluate the effects of multivalent buffer and ionic strength on Cellufine™ MAX IB. HCP was obtained from flow-through fraction pool. Figure 2 showed residual CHO-HCP levels from each run at low (6 mS/cm) or high (14 mS/cm) conductivity conditions. Results showed that Cellufine™ MAX IB resin exhibited superior CHO-HCP removal under existing citrate buffer and high salt.

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