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WALTHAM, Mass., March 26, 2014 (GLOBE NEWSWIRE) -- Repligen Corporation (Nasdaq:RGEN), a technology leader in pre-packed columns for the cost-effective purification of biologic drugs, today announced the commercial launch of its OPUS
® 45 cm diameter columns ("OPUS 45") with the largest capacity currently available on the market. OPUS columns, which now range from 1.2 cm to 45 cm in diameter, are delivered packed with chromatography media used to purify monoclonal antibodies and other biologic drugs. OPUS technology increases facility flexibility, improves the speed of process development and reduces the cost of biopharmaceutical manufacturing by decreasing the set-up, cleaning and validation times associated with traditional purification technologies. OPUS 45 was designed to process large single-use bioreactor harvests and will be formally launched at Biopharmaceutical Development & Production Week being held March 24-27 at the Hilton Bayfront Hotel in San Diego.
"Since launching process scale OPUS columns in 2012, our biopharmaceutical customers have embraced our "any resin, any size" approach which offers the most flexibility among run-ready chromatography options," said Steve Tingley, Vice President of Bioprocessing Sales & Marketing for Repligen. "Since then, our customers have requested OPUS columns that are capable of processing harvests from larger disposable fermentors for producing clinical-stage drug candidates and niche commercial biologics. In response we are introducing OPUS 45 and have already begun to fulfill orders."
In November 2013, Repligen completed a 9,000 square foot expansion of its manufacturing facilities at its Waltham headquarters which included a dedicated production suite built to ISO 7 clean room specifications. As a result, the Company more than doubled its manufacturing capacity for its OPUS line of chromatography columns and established an appropriately controlled environment to satisfy the Good Manufacturing Practices (GMP) standards of the Company's biopharmaceutical customers.
OPUS chromatography columns are available and can be ordered through Repligen's bioprocessing product website:
About Repligen Corporation
Repligen Corporation (Nasdaq:RGEN) is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide. We are the leading manufacturer of Protein A affinity ligands, a critical component of Protein A media that is used to separate and purify monoclonal antibody therapeutics. Our growth factor products are used to increase cell growth and product yield during the fermentation stage of biologic drug manufacturing. In addition, we developed and market an innovative line of "ready-to-use" chromatography columns under our OPUS
® brand (Open Platform User Specified) that we deliver pre-packed to our biopharmaceutical customers with their choice of purification media. Repligen's corporate headquarters are in Waltham, MA (USA) and our manufacturing facilities are located in Waltham, MA and Lund, Sweden.
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 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.
CONTACT: Sondra S. Newman
Director Investor Relations