Celliance Facility in Lawrence, Kansas Meets ISO 9000 Requirements
Celliance Corporation, a wholly-owned subsidiary of Serologicals Corporation announced that its Lawrence, Kansas manufacturing facility has a quality management system that successfully meets the requirements of ISO 9001:2000. ISO 9001:2000 is part of a set of standards published by the International Organization for Standardization (ISO) that establishes a supplier's ability to provide consistent and conforming goods or services. The facility was ISO certified by an independent third party, TUV America Group.
The Lawrence facility manufactures EX-CYTE(R), the leading cell culture growth supplement. The 43,000 square foot facility meets all cGMP requirements and can produce 100,000 liters of EX-CYTE(R) annually.
"The ISO certification ensures our customers that we have established a systematic approach to quality management," said David L. Bellitt, President of Celliance. "This marks the successful completion of another key milestone for this new state-of-the-art facility. The Lawrence facility now joins our other Celliance manufacturing facilities in Kankakee, Ill., Milford, MA., Toronto, Ontario and Livingston, UK, in being ISO certified."
In addition to the ISO certification, the Lawrence facility is continuing production validation activity which includes detailed customer audits and extensive testing of batches of product to ensure compliance with all customer specifications.
Celliance offers an expanding array of bioprocessing products and services including diagnostic products, contract research and manufacturing services, and cell culture media supplements. Key products include: EX-CYTE(R), the largest selling cell growth supplement; Probumin(TM), a proprietary line of bovine albumin; and Incelligent(TM), the Company's recombinant human insulin. It is also the world's leading provider of monoclonal antibodies for the blood typing industry. Celliance is a Serologicals company based in Atlanta, GA.
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