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Custom Affinity Chromatography Resin Promises High Yield Purification in Clinical and Commercial GMP Downstream Processing
Navigo Proteins GmbH, a premier protein engineering company, developer of affinity ligands for custom chromatography solutions, and eleva GmbH, a manufacturer of superior biologics derived from its proprietary moss expression system, announce the successful implementation of a customized affinity chromatography resin into the purification process of Eleva’s Complement- Factor H, CPV-101, for its coming clinical development.
Using Navigo’s proprietary platform, an affinity chromatography resin has been developed, which purifies enzymatically active Factor H efficiently from moss cell culture medium. The resin delivers a robust, scalable, and predictable Factor H downstream process, thereby addressing inherent challenges of conventional purification processes. The validation for clinical and commercial resin supply to support CPV-101 future development path is ongoing.
Florian Settele, Navigo’s Head of Precision Capturing®, commented: “We are delighted to be able to work together with a great Eleva team to successfully develop an innovative affinity chromatography solution for the purification of CPV-101. Our custom affinity chromatography technology immediately showed its full potential for efficient production of CPV-101 with excellent purity and yield. We are looking forward to continue our support of Eleva by delivering validated resin for production of clinical grade material.”
Sören Boller, Eleva’s Head of Downstream Process Development added: “After receiving the affinity chromatography resin for the purification of CPV-101 from Navigo, we performed numerous experiments to challenge the resin. We were amazed to see an excellent purity after only a single purification step. This powerful tool allows for flexible design of a CPV-101 purification strategy, eventually leading to a successful purification of CPV-101. We are looking forward to continuing the successful collaboration with Navigo and are excited to test the affinity resin in larger scale.
Based in Freiburg, Germany, Eleva is developing novel biological therapies for complement disorders and metabolic diseases. The privately held company leverages its unique moss-based production platform to produce supreme biologics like antibodies, replacement enzymes, or fusion toxins. Eleva has successfully developed drug candidates into clinical phases.
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 enable 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.