“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,” said Ralf Kuriyel, senior vice president R&D, Repligen. “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.”
Henning Afflerbach, CEO, 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.