Repligen and Navigo GmbH Announce Launch of Industry-First Protein A Ligand for Purification of pH Sensitive Antibodies
2021年9月9日 - 8:30PM
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 CorporationRepligen 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 GmbHNavigo 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 StatementsThe
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. NewmanGlobal Head
of Investor Relations(781) 419-1881 snewman@repligen.com
Navigo GmbH Contact:Laura MüllerBusiness
Development Manager+49 (0)345
27996337laura.mueller@navigo-proteins.com
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