Repligen and Navigo GmbH Launch Industry-First Protein A Ligand for Purification of pH-Sensitive Antibodies

Repligen Corporation, a life sciences company focused on bioprocessing technology, and Navigo Proteins GmbH, a protein engineering company, announced on Sept. 9, 2021, the completion of the development and validation of a novel protein A ligand, the NGL-Impact A Hi pH, that addresses antibody aggregation in low pH elution buffers and challenges associated with Fc-fusion proteins.

Protein A affinity ligands enable the affinity purification of monoclonal antibody-based biologic drugs in Protein A chromatography media. However, according to a company press release, this is the first ligand to address antibody aggregation in low pH elution buffers. It was specifically developed to address pH-sensitive antibodies and Fc-fusion proteins, but it can also be considered for “platform” use due to its broad pH operating range and high performance across all antibodies.

“[This new 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 of R&D at Repligen, in the company press release. “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.”

“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,” said Henning Afflerbach, CEO of Navigo Proteins, in the press release. “We believe the performance enabled by this ligand will prove very attractive in the market, for purification of all antibodies and Fc-containing proteins.”

Source: Repligen