WALTHAM, Mass., and HALLE (Saale), Germany – February 8, 2021 – Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, and Navigo Proteins GmbH (“Navigo”), a premier protein engineering company specializing in novel affinity ligand development, today announced that they have completed the development and initiated the commercial launch of NGL COVID-19 Spike Protein Affinity Resin, a novel affinity resin to be utilized in the purification of COVID-19 vaccines.
The availability of this COVID-19 affinity resin is the result of an accelerated program to provide COVID-19 vaccine manufacturers with a high purity capture step, decreasing processing time and significantly improving overall yield in the production of these critical vaccines.
Working closely with Navigo Proteins on the ligand development and partnering with Purolite Life Sciences on Praesto® agarose bead technology, the resulting product meets all the expected requirements of a high-performance resin including very high selectivity, high dynamic binding capacities and caustic stability over multi-cycle use.
Ralf Kuriyel, Repligen Senior Vice President R&D said, “We are very pleased to launch this resin and are very encouraged by the positive customer feedback on its overall performance in the development and manufacture of Spike Protein based vaccines.”
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 resulted in getting a Spike resin into the market in less than 10 months – it’s a tremendous achievement.”
NGL COVID-19 Spike Protein Affinity Resin will be manufactured and marketed by Repligen. Resin samples are available immediately and can be ordered in Repligen’s pre-packed OPUS® columns to expedite and support evaluations and scale-up. Orders for validated and commercial resin are also being accepted currently.
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, MA (USA), and we have additional administrative and manufacturing operations in Marlborough, MA; Bridgewater, NJ; Rancho Dominguez, CA; Clifton Park, NY; Lund, Sweden; Breda, The Netherlands and Ravensburg, Germany.
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.
The following constitutes a “Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, express or implied statements regarding market demand for spike protein ligands and related resins, customer acceptance of these ligands and resins, manufacturing scale-up and validation activities for the commercialization of spike protein ligands and related resins, and the expected synergies from Repligen’s partnership with Navigo constitute forward-looking statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” “anticipate,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our ability to successfully grow our bioprocessing business, including as a result of acquisition, commercialization or partnership opportunities; our ability to successfully integrate any acquisitions, our ability to develop and commercialize products and the market acceptance of our products; reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition; our ability to compete with larger, better financed bioprocessing, pharmaceutical and biotechnology companies; our compliance with all Food and Drug Administration and EMEA regulations; our volatile stock price; and other risks detailed in Repligen’s Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 on file with the Securities and Exchange Commission and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Repligen contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and Repligen does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.
Sondra S. Newman
Global Head of Investor Relations