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Repligen Announces Market Launch of OPUS® 80R, Reinforces Technology Leadership in Pre-Packed Chromatography

Company Release - 3/20/2018 7:30 AM ET

- First and only available 80 cm diameter pre-packed column to address large-scale clinical and commercial-scale manufacturing of biological drugs -

WALTHAM, Mass., March 20, 2018 (GLOBE NEWSWIRE) -- 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® Benefits
OPUS 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 Corporation
Repligen 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 Statements
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, 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.

Repligen Corporation

Sondra S. Newman
Senior Director Investor Relations
(781) 419-1881

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Source: Repligen Corporation