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

Rhea-AI Summary

Repligen Corporation (NASDAQ:RGEN) and Navigo Proteins GmbH announced the successful development of a novel protein A ligand called NGL-Impact A Hi pH. This innovative ligand addresses critical challenges in purifying pH sensitive antibodies and Fc-fusion proteins, notably reducing antibody aggregation during purification. Customer evaluations showcased a two-fold decrease in aggregate formation while maintaining high dynamic binding capacity. The ligand is set for commercialization via a new resin later this year, potentially offering significant cost and time savings for developers in the biopharmaceutical industry.

Positive

• Introduction of NGL-Impact A Hi pH ligand, enhancing antibody purification efficiency.
• Demonstrated two-fold lower levels of aggregate formation during Protein A elution.
• High dynamic binding capacity and excellent caustic stability reported.
• Potential for significant cost- and time savings for developers of pH sensitive antibodies.

Negative

• None.

WALTHAM, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, and Navigo Proteins GmbH (“Navigo”), today announced they have completed development and validation of a novel protein A ligand that overcomes challenges associated with the purification of pH sensitive antibodies and Fc-fusion proteins. Named NGL-Impact^® A Hi pH, the new ligand is the first to address antibody aggregation in low pH elution buffers. While developed specifically to address pH sensitive antibodies and Fc-fusion proteins, NGL-Impact A Hi pH ligand demonstrates high performance for all antibodies, and can be considered for “platform” use due to its broad pH operating range.

Ralf Kuriyel, Repligen Senior Vice President R&D, said, “This new best-in-class ligand addresses one of the major pain points in antibody drug purification which is the formation of aggregates during Protein A elution. 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.”

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 again resulted in delivering a differentiated ligand product that addresses an industry bottleneck. 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. We believe the performance enabled by this ligand will prove very attractive in the market, for purification of all antibodies and Fc containing proteins.”

Protein A affinity ligands are the critical component of Protein A chromatography media that enable the affinity purification of monoclonal antibody-based biologic drugs. There are currently more than 120 monoclonal antibodies and Fc-fusion proteins that have received U.S. FDA regulatory approval and more than 600 are at various stages of clinical development.  

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, Massachusetts, with additional administrative and manufacturing operations worldwide. The majority of our manufacturing sites are located within the U.S. (California, Massachusetts, New Jersey and New York), and outside of the U.S. we have sites in Estonia, France, Germany, Ireland, the Netherlands and Sweden.

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.

Repligen Forward Looking Statements
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 high pH ligands and related resins, customer acceptance of these ligands and resins, manufacturing scale-up and validation activities for the commercialization of high pH 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, 2020 and Quarterly Report on Form 10-Q for the quarter ended June 30, 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.

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

Navigo GmbH Contact:
Laura Müller
Business Development Manager
+49 (0)345 27996337
laura.mueller@navigo-proteins.com 

FAQ

What is NGL-Impact A Hi pH developed by Repligen Corporation?

NGL-Impact A Hi pH is a novel protein A ligand designed to improve the purification of pH sensitive antibodies and Fc-fusion proteins by reducing aggregation.

When will the NGL-Impact A Hi pH ligand be commercialized?

The NGL-Impact A Hi pH ligand is expected to be commercialized later this year.

How does NGL-Impact A Hi pH improve antibody purification?

It reduces aggregate formation during purification while maintaining high dynamic binding capacity and stability.

What are the implications of NGL-Impact A Hi pH for biopharmaceutical developers?

It promises significant cost- and time savings for developers working with pH sensitive antibodies and Fc-fusion proteins.

What is the stock symbol for Repligen Corporation?

The stock symbol for Repligen Corporation is RGEN.