San Diego, CA – 4 September 2010 -- Eurogentec S.A. announced today that its North American subsidiary, Eurogentec North America, Inc., has received ISO 13485:2003
certification for the production and sale of oligonucleotides for the in vitro Diagnostic (IVD) market. The ISO 13485 quality standard is
recognized as the international standard for quality management systems specific to the design, development and production of medical
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.
Dr. Peter Haima
Global Director, IVD Services
Rue Bois Saint-Jean 5
4102 Seraing, Belgium
Tel: +32 (4) 372 76 35
Fax: +32 (4) 372 75 00
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