Repligen and Navigo Proteins Announce Achievement of Key Milestone in Developing an Affinity Resin for the Purification of CO...
October 01 2020 - 6:30AM
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 their successful
development of an affinity ligand targeting the 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 the
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 applications.”
Dr. Henning Afflerbach, CEO of Navigo Proteins
said, “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, Repligen and Navigo
initiated 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 their strategic partnership, Repligen and
Navigo deployed their expertise in discovery, development,
manufacturing and commercialization of customized affinity ligands
and chromatography resins to provide a rapid purification solution
to support the development and scale-up of potential COVID-19
vaccines.
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 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.
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
6330oliver.schub@navigo-proteins.com
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