Navigo Proteins GmbH, a premier protein engineering company specializing in novel affinity ligand development based in Germany, and Repligen Corporation, a US headquartered life sciences company focused on bioprocessing technology leadership has announced their successful development of an affinity ligand targeting the SARS-CoV‑2 spike protein, to be utilized in the purification of COVID-19 vaccines.

The program has entered stage two, which is focused on both scaling up manufacturing of this ligand, and on the development and validation of the related affinity chromatography resin. The affinity resin aims to provide end users with a rapid, high purity capture step, decreasing processing time and potentially improving overall yield in the manufacturing of critical COVID-19 vaccines. Repligen anticipates that the final resin product will be commercially available in early 2021.

Ralf Kuriyel, Repligen Senior Vice President R&D said, "We are very pleased to report this progress through our partnership with Navigo Proteins, which enables us to rapidly screen and develop commercially viable affinity ligands and resins to support the development and scale-up of COVID-19 vaccines. We look forward to providing additional feedback in the coming months as customers evaluate the potential of this chromatography ligand and resin in COVID-19 applications."

Dr. Henning Afflerbach, CEO of Navigo Proteins stated, "This joint endeavor is the logical continuation of our journey to develop platform-based purification solutions for biopharmaceutical downstream processing. Our affinity chromatography technology - Precision Capturing®- is a solution to cope with ever-increasing regulatory and capacity requirements of the entire biopharmaceutical manufacturing industry, including vaccines."

With a surge in the demand for global coronavirus vaccine manufacturing capacity, Navigo and Repligen initiated the development of a robust and scalable purification product for COVID-19 vaccine manufacturing. Spike proteins are a characterizing feature of SARS-CoV-2, the virus that causes COVID-19. The spike protein is the primary antigen being evaluated in clinical trials to induce an immune response as a COVID-19 vaccine.

Under the strategic partnership, Navigo Proteins and Repligen deployed their expertise in discovery, development, manufacturing and commercialization of customized chromatography affinity ligands and resins to provide a rapid purification solution to support the development and scale-up of potential COVID-19 vaccines.