Repligen Corporation, a life sciences company focused on bioprocessing technology leadership, 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.
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.
About Repligen Corporation
Repligen Corporation is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that increase efficiencies in the process of manufacturing biological drugs. We are inspiring advances in bioprocessing for the customers we serve; primarily biopharmaceutical drug developers and contract development and manufacturing organizations (CDMOs) worldwide. Our corporate headquarters are located in Waltham, Massachusetts, with additional administrative and manufacturing operations worldwide. The majority of our manufacturing sites are located within the U.S. (California, Massachusetts, New Jersey and New York), and outside of the U.S. we have sites in Estonia, France, Germany, Ireland, the Netherlands and Sweden.
About Navigo Proteins GmbH
Navigo Proteins is a premier protein engineering company, specialized in creating novel affinity ligands for custom affinity purification of complex biologics (Precision Capturing®) and as ligands in biotherapeutic drug candidates (Precision Targeting). Navigo’s unique protein engineering expertise is based on the company’s proprietary platform of different small and stable, yet highly engineerable scaffold proteins. Navigo’s Precision Capturing unit creates affinity ligands and chromatography resins that specifically bind and purify biologics, even without Fc part and notably enables platformized one-step downstream processes. Precision Capturing is based on an artificial Protein A scaffold, combining the downstream processing industry-accepted virtues of Protein A with novel selectivities and mild elution conditions. Precision Capturing is applicable for purifying recombinant proteins, monoclonal antibodies, viruses, VLPs and other biologics. Navigo works with renowned global partners to convert its affinity ligands into ready-to-use, GMP-compliant affinity resins for large-scale, commercial biologics downstream processing.