A new product development approach will be described here for the affinity capture of monoclonal antibodies (MAbs) from cell culture materials using a novel base stable rProtein A ligand with up to six available Fc binding sites. The resin is based on a stable cellulose bead structure with excellent flow properties combined with the affinity ligand immobilized at multiple sites to yield a robust next generation MAb capture resin with a high level of binding capacity.
These resins have been developed to retain >95% of their original binding capacity after >100 cycles of reuse under 0.1M NaOH clean-in-place (CIP) conditions. Polyclonal and MAbs show efficient elution at pH 3.5 with a 0.1M glycine HCL or 60 mM acetic acid buffers. This new Cellufine Protein A suite of resins developed by JNC will offer flexibility for future continuous workflow formats as well as being compatible with existing chromatography systems.
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