Repligen Corporation and Navigo Proteins GmbH announced they have completed development and validation of a novel protein A ligand that overcomes challenges associated with the purification of pH sensitive antibodies and Fc-fusion proteins. Named NGL-Impact® A Hi pH, the new ligand is the first to address antibody aggregation in low pH elution buffers. While developed specifically to address pH sensitive antibodies and Fc-fusion proteins, NGL-Impact A Hi pH ligand demonstrates high performance for all antibodies, and can be considered for platform use due to its broad pH operating range.
Protein A affinity ligands are the critical component of Protein A chromatography media that enable the affinity purification of monoclonal antibody-based biologic drugs. There are currently more than 120 monoclonal antibodies and Fc-fusion proteins that have received U.S. FDA regulatory approval and more than 600 are at various stages of clinical development.