Repligen Announces ISO 9001:2000 Cer... ( WALTHAM Mass. Feb. 12 /- Repligen Cor...)

Repligen Announces ISO 9001:2000 Certification

Date:2/12/2009

WALTHAM, Mass., Feb. 12 /PRNewswire-FirstCall/ -- 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 re
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SOURCE Repligen Corporation
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