Eurogentec North America, Inc. Receives Iso 13485:2003 Medical Device Certification for the Production and Sale of Ivd Oligonucleotides
Published: Sep 10, 2010
ISO 13485 certification provides assurance to our diagnostic clients that Eurogentec North America has established highly reliable, effective and reproducible processes for manufacturing critical oligonucleotide components used in Lab Developed Tests (LDTs) or molecular diagnostic assays that received 510(k) clearance or Premarket Approval (PMA) from the FDA. It also confirms our compliance with the European IVD Directive 98/79 EC and U.S. FDA Quality System Regulations (QSR) for Good Manufacturing Practices (FDA 21 CFR Part 820 QSR/cGMP) and Analyte Specific Reagents (FDA 21 CFR Part 820, 21 CFR 809.10(e), 809.30, 864.4020).
Eurogentec undertook this rigorous medical device certification as part of a strategic investment to meet and exceed the quality requirements of the molecular diagnostics market. Eurogentec is now the sole custom oligonucleotide Contract Manufacturing Organization (CMO) to be fully cGMP compliant and have three (3) ISO 13485 certified and fully harmonized cleanroom sites spanning three (3) continents: North America, Europe and Asia. The ability to manufacture at any of three mirror sites provides customers with significant added value and key advantages over other suppliers: an uninterrupted, reliable supply of high-quality critical IVD and cGMP manufactured components, ensuring business continuity; the ability to manufacture probes, primers and control sequences at different sites, mitigating the risk of cross contamination; and the ability to manufacture within or near the regions in which assays will be distributed and regulated by their local regulatory agencies.
“ISO 13485 certification is another important milestone in Eurogentec’s strategy to further grow our presence in the rapidly expanding North American molecular diagnostic market,” said Diane Wolfe, General Manager of Eurogentec North America, Inc.
In addition to ISO 13485, Eurogentec North America has achieved ISO 9001:2008 certification for the manufacture and sales of Research Use Only (RUO) oligonucleotides used in the discovery and feasibility phases of assay development.
Dr. Peter Haima, Director for Eurogentec’s IVD contract manufacturing services, commented that “ISO 13485 certification of our North American subsidiary demonstrates Eurogentec’s leadership in contract manufacturing and our undivided commitment to the molecular diagnostic markets. With our newly certified North American cleanroom-manufacturing facility, we can now offer ‘Made in the USA’ GMP/ QSR compliant oligos to diagnostic companies and CLIA labs. We are also positioned to respond rapidly to the increasing need for GMP- compliant ASR-oligos to CLIA labs; a need resulting from the FDA’s increasing oversight of LDTs.”
Eurogentec S.A. is a leading global supplier of innovative reagents, kits, specialty products and custom services to scientists in the life science, biotechnology, pharmaceutical and diagnostic markets. The Company provides a wide range of expertise in small- and large- scale DNA and RNA manufacturing. Together with its subsidiary AnaSpec (Fremont, California), Eurogentec is also a leading provider of integrated proteomics solutions for life science research and diagnostics with expertise in peptides synthesis, labeled peptides, antibodies, fluorescent dyes and enzyme activity assays.
The Company is also an experienced CMO, operating full-service, state-of-the-art GMP- and ISO 13485:2003-certified manufacturing facilities in Belgium that provide high-value custom biologics (including PCR enzymes) and a wide range of oligonucleotide-based components for diagnostic and therapeutic applications.
Eurogentec’s GMP/QSR compliant and ISO 13485:2003 certified clean room oligonucleotide manufacturing facility in Europe is complemented by additional GMP production facilities in Asia and North America. Headquartered in Liège, Belgium, Eurogentec is part of Kaneka Corporation group of Companies, and has subsidiaries in France, Germany, the UK, the Netherlands, Switzerland and North America with additional manufacturing facilities in the United States, Japan and Singapore. The Company employs 375 people globally.
Please visit www.eurogentec.com for more information.
contacts EUROPE Dr. Peter Haima Global Director, IVD Services Eurogentec S.A. Rue Bois Saint-Jean 5 4102 Seraing, Belgium Tel: +32 (4) 372 76 35 Fax: +32 (4) 372 75 00
NORTH AMERICA Mr. Harrison Ransom IVD Business Development Manager Eurogentec North America, Inc. 11111 Fl intkote Avenue San Diego, CA 92121-1222 Tel: +1(415) 681-4927 Fax: +1(415) 680-1686