Repligen Announces Market Launch of OPUS® 80R, Reinforces Technology Leadership in Pre-Packed Chromatography
March 20 2018 - 7:30AM
- First and only available 80 cm diameter
pre-packed column to address large-scale clinical and
commercial-scale manufacturing of biological drugs -
Repligen Corporation (NASDAQ:RGEN), a life sciences company focused
on bioprocessing technology leadership, today announced the
commercial launch of its next-generation OPUS® column, the OPUS
80R, which is the largest pre-packed column on the market and is
suitable for late-stage clinical into commercial-scale
manufacturing of biological drugs. OPUS columns are used in
downstream manufacturing processes, to purify biologics including
monoclonal antibodies, recombinant proteins, vaccines and gene
therapies. The OPUS product line is the industry’s broadest and
most scalable with packed bed volumes now ranging from 50
microliters to 150 liters. The groundbreaking OPUS 80R columns are
being highlighted in a Technology Workshop on March 21st at the
BioProcess International West conference in San Francisco.
Tony J. Hunt, President and Chief Executive
Officer said, “We are excited to be launching our 80 cm OPUS column
with resin recovery, which reflects not only our responsiveness to
customer requests, but also the expertise and capability of our
R&D team. Customer interest in OPUS 80R is high and we look
forward to fulfilling orders during the second quarter of this
year, as we reinforce our position as a technology and market
leader in the pre-packed column space.”
Stephen Tingley, Vice President of Sales said,
“Our customers have embraced the flexibility and scalability that
the OPUS brand uniquely represents, and OPUS columns are currently
being used in hundreds of clinical campaigns. The addition of OPUS
80R opens up many more opportunities for us, especially in
late-stage clinical and commercial, as it enables our customers to
process greater than 10 kilograms of protein in a single run.
OPUS® BenefitsOPUS columns are
“campaign-use” disposables, delivered to customers as a run-ready
alternative to internal self-packing of glass columns. OPUS
technology increases facility versatility, improves the speed of
process development and reduces the cost of biopharmaceutical
manufacturing by decreasing the set-up, cleaning and validation
times associated with using traditional glass columns. The OPUS
product line ranges from 0.5 cm to 80 cm in diameter and provides
unparalleled pre-packed column flexibility to biopharmaceutical and
contract manufacturing customers. Only Repligen will pack any
chromatography resin, packed to any bed height, according to our
customers’ preferences. Our largest columns (OPUS 45, 60 and 80 cm
diameter) are further differentiated by a proprietary resin
recovery port, providing customers assurance that if necessary,
valuable chromatography resins can be retrieved. Over the past
several years, adoption rates of pre-packed columns have
accelerated, with strength expected to continue as manufacturers
transition to more flexible and less capital and resource intensive
production processes.
About Repligen
CorporationRepligen Corporation (NASDAQ:RGEN) is a global
bioprocessing company that develops and commercializes highly
innovative products that deliver cost and process efficiencies to
biological drug manufacturers worldwide. Our portfolio includes
protein products (Protein A affinity ligands, cell culture growth
factors), chromatography products (OPUS® pre-packed columns,
chromatography resins, ELISA kits) and filtration products
(including XCell™ ATF systems, TangenX™ SIUS™ flat sheet TFF
cassettes, and Spectrum KrosFlo™ hollow fiber TFF cartridges and
systems). The Protein A ligands and growth factor products that we
produce are essential components of Protein A affinity resins and
cell culture media, respectively. Protein A affinity resins are the
industry standard for downstream separation and purification of
monoclonal antibody-based therapeutics. Our growth factors are used
in upstream processes to accelerate cell growth and productivity in
a bioreactor. Our innovative line of OPUS® chromatography columns,
used in downstream processes for biological drug purification, are
delivered pre-packed and tailored to our customers’ choices of
resin and bed height. Our XCell™ ATF Systems, available in
stainless steel and single-use configurations, are used upstream to
continuously eliminate waste from a bioreactor, to concentrate
cells and increase product yield. Single-use SIUS™ TFF cassettes
and hardware are used for biologic drug concentration in downstream
filtration processes. Spectrum KrosFlo™ TFF cartridges and systems
are used in both upstream and downstream filtration processes.
Repligen’s corporate headquarters are in Waltham, MA (USA), with
additional administrative and manufacturing operations in
Shrewsbury, MA, Rancho Dominguez, CA, Lund, Sweden and Ravensburg,
Germany.
Forward-Looking StatementsThis
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,
statements identified by words like "believe," "expect," "may,"
"will," "should," "seek," or "could" and similar expressions,
constitute forward-looking statements. 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 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; the market opportunities for
the OPUS® brand chromatography columns; the results achievable with
our OPUS® technology; our ability to compete with larger, better
financed bioprocessing, pharmaceutical and biotechnology companies;
our compliance with all Food and Drug Administration regulations;
our compliance with GMP and other manufacturing standards; the
capacity of our expanded manufacturing facilities; our ability to
obtain, maintain and protect intellectual property rights for our
products; the risk of litigation regarding our intellectual
property rights; our limited sales capabilities; 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.
Source: Repligen
Corporation
Contact: Sondra S.
NewmanSenior Director Investor Relations(781) 419-1881
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