Repligen Corporation a life sciences company focused on bioprocessing technology leadership, and Navigo Proteins GmbH (“Navigo”), 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.
Ralf Kuriyel, Repligen Senior Vice President R&D, said, “This new best-in-class ligand addresses one of the major pain points in antibody drug purification which is the formation of aggregates during Protein A elution. Our new NGL-Impact A Hi pH ligand has demonstrated in customer evaluations two-fold lower levels of aggregate formation while maintaining high dynamic binding capacity and excellent caustic stability. We have completed all scale-up and validation work and now look forward to this ligand being commercialized on a new resin later this year, through our partnership with Purolite.”
Dr. Henning Afflerbach, CEO of Navigo Proteins, said, “The rapid deployment of our Precision Capturing technology and working in parallel with the Repligen team has again resulted in delivering a differentiated ligand product that addresses an industry bottleneck. The introduction of a high pH, high performing ligand into the market represents a potential real cost- and time savings for developers of pH sensitive antibodies and Fc-fusion proteins. We believe the performance enabled by this ligand will prove very attractive in the market, for purification of all antibodies and Fc containing proteins.”
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.