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Navigo Proteins and Repligen Announce Achievement of a Key Milestone in Development of an Affinity Resin for the Purification of COVID-19 Vaccines

HALLE (Saale), Germany, and WALTHAM, Mass. – October 1, 2020 – Navigo Proteins GmbH (“Navigo”), a premier protein engineering company specializing in novel affinity ligand development, and Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership today 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.

About Navigo Proteins GmbH
Navigo Proteins is a premier protein engineering company, specialized in creating novel affinity ligands for PRECISION CAPTURING® and PRECISION TARGETING. These proteins serve either as highly specific binders for custom affinity purification of complex biologics or as ligands in active biotherapeutic or diagnostic molecules. Navigo’s unique protein engineering expertise is based on the company’s proprietary platform of different small and stable, yet highly engineerable scaffold proteins. The company’s PRECISION CAPTURING® platform creates affinity ligands and chromatography resins that can specifically bind and purify literally any biologic, even without Fc part and notably enables one-step platform downstream processes. PRECISION CAPTURING® is based on Protein A-derived scaffold variants, combining the industry-accepted virtues of protein A with entirely novel selectivity & mild elution conditions. PRECISION CAPTURING® is applicable for purifying recombinant proteins, monoclonal antibodies, viruses, VLPs and other biologics. Navigo works with renowned partners to convert its affinity ligands into ready-to-use, GMP-compliant affinity resins for commercial downstream processing.

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.
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 most recent Annual Report on Form 10-K 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.

Navigo Contact:
Dr. Oliver Schub
Director Business Development
+49 (345) 2799 6330
oliver.schub@navigo-proteins.com

Repligen Contact:
Sondra S. Newman
Global Head of Investor Relations
(781) 419-1881
snewman@repligen.com

Repligen Announces Agreement with Navigo Proteins for the Exclusive Co-Development of Next Generation Affinity Ligands
MABFILIN AND FABFILIN - NEW ANTIBODY-SCAFFOLD FUSION FORMATS FOR MULTISPECIFIC TARGETING CONCEPTS

Protein based binding molecules have a broad applicability from therapeutic to technical use. Monoclonal antibodies represent the major class of this type of agents complemented by innovative approaches using scaffold proteins with tailor-made properties. Various concepts for new formats combining antibody chains or antibody fragments and fusions with other entities have been developed recently. This strategy opens up options to design molecules with biophysical, biochemical and pharmacological characteristics in a broad range while simultaneously addressing several targets or epitopes. The demand for such compounds is still growing as reflected by the literature and further new ideas are expected. In this context we developed so called Mabfilin and Fabfilin molecules. The formats synergistically bring together the classical antibody or fragments thereof supplemented with additional binding moieties, the Affilin® molecules. These are based on the scaffold ubiquitin endowed with novel targeting properties by local randomization and selection from combinatorial libraries. Mab-/Fabfilin variants show advantageous biochemical properties and open a new route for the development of multispecific compounds for flexible applications.

1046-5928/ © 2018 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/BY-NC-ND/4.0/).

AFFINITY CHROMATOGRAPHY FOR VACCINES MANUFACTURING: FINALLY READY FOR PRIME TIME?

Affinity chromatography is among the most powerful separation techniques, achieving the finest separation with high yields even in the most challenging feed streams. Incorporating affinity chromatography in vaccine purification has long been attempted by researchers to improve unit yield and purity with the secondary goal of reducing the number of downstream process operations. Despite the success in laboratory-scale proof of concept, implementation of this technique in pilot or cGMP manufacturing has rarely been realised due to technical and economic challenges in design and manufacturing of ideal ligands as well as availability of high-productivity chromatography media. This paper reviews evolving technologies in engineered ligands and chromatography media that are encouraging companies to revisit the possible use of affinity chromatography in larger scale vaccine purification. It is postulated that commercial-scale implementation of high throughput single-use affinity chromatography can significantly simplify process architecture, improve productivity and flexibility, and reduce cost of goods.

0264-410X/ 2018 The Authors. Published by Elsevier Ltd.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

NAVIGO EXPANDS LAB SPACE IN HALLE

The Navigo team has expanded its lab space now under one roof in Halle/Saale on the Weinberg Campus, Heinrich-Damerow-Str 1 – 06120 Halle/Saale, Germany. The lab expansion became necessary to meet the growing demand of partner client projects and the continuously growing team.