Repligen and Navigo Proteins Announce the Launch of an Affinity Resin for the Purification of COVID-19 Vaccines
February 08 2021 - 7:36AM
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
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, 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
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.
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.
Repligen Contact: Sondra S. NewmanGlobal Head
of Investor Relations(781) 419-1881 snewman@repligen.com
Navigo Contact:Dr. Oliver SchubDirector
Business Development+49 (345) 2799 6
363oliver.schub@navigo-proteins.com
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