WALTHAM, Mass., Feb. 12 Repligen Corporation (Nasdaq: RGEN), a global leader in the manufacture of recombinant Protein A products, announced today that the Company has received ISO 9001:2000 (ISO) certification, the international standard for best practices for manufacturing and quality systems. ISO certification was granted for the quality management system supporting the manufacture of products and related services underlying its Protein A business. Repligen has supplied Protein A products to the biopharmaceutical industry for more than 20 years and pursued ISO certification to demonstrate that its operations meet the high quality standard which has global acceptance within the industry.
"We are very proud to have received ISO certification for our Protein A business, a milestone that reinforces our longstanding commitment to quality and customer satisfaction," said Walter C. Herlihy, President and Chief Executive Officer of Repligen.
Repligen is the world's leading supplier of recombinant Protein A, a consumable used in the manufacture of therapeutic monoclonal antibodies. There are approximately 20 monoclonal antibodies that have received regulatory approval with more than 200 products in various stages of clinical development. The worldwide revenues from this class of drug were approximately $35 billion in 2008. Monoclonal antibodies are the largest and one of the fastest growing classes of drug in the biopharmaceutical industry.
ISO 9001:2000 is a quality management system standard that represents an international consensus on the best quality management practice. Created and published by the International Organization for Standardization, a network of the national standards institutes representing 160 countries, ISO standards define globally relevant management and process related requirements that provide the framework for customer satisfaction, consistent products and services and continuous improvement. Repligen's certification covers all processes in design, development, manufacturing and servicing of its Protein A products.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for neurological disorders. In addition, we are the world's leading supplier of recombinant Protein A, the sales of 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 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.
SOURCE Repligen Corporation