WALTHAM, Mass., Oct. 19 /PRNewswire-FirstCall/ -- Repligen Corporation today reported that it has completed the final phase of expansion of its manufacturing facility with increased capabilities and capacity. The construction of this multi-thousand liter E. coli fermentation suite enables the complete manufacture of recombinant biologics, such as recombinant Protein A, including fermentation, recovery, purification, packaging, quality control and quality assurance at our facility in Waltham, Massachusetts. Previously this year, we completed the construction of a third large-scale purification suite, which allows us to increase our manufacturing throughput in excess of 200 kilograms of recombinant protein each year.
"The creation of this facility has been in response to the potential for continued growth of the monoclonal antibody market, which in turn drives demand for our Protein A products," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We believe that we will be able to meet market demand for Protein A for the next several years without the need for significant additional capital expenditure. The addition of fermentation to our manufacturing capabilities will decrease our reliance on external contractors and increase our ability to maintain supply chain security for our customers in an increasingly risk averse environment."
Repligen has supported the manufacture of its products through Drug Master Files with the Food and Drug Administration for more than 20 years and we have a formal system and commitment to continued Business Continuity Planning. Repligen is the world's leading supplier of recombinant Protein A, a consumable used in the manufacture of therapeutic monoclonal antibodies, the fastest growing segment of the biotechnology market.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for diseases that affect the central nervous system. In addition, we currently market two commercial products, Protein A and SecreFlo(R), which partially fund the advancement of our development pipeline while supporting our financial stability. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from http://www.repligen.com.
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. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets and projected growth in product sales, 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: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, 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 and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen's filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.
Repligen CorporationCONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer,+1-781-419-1900, or Laura Whitehouse, Vice President, Market Development,+1-781-419-1812, both of Repligen Corporation
Web site: http://www.repligen.com/
