Eurogentec S.A. (“Eurogentec”) announced today that Nippon EGT, a member of the Eurogentec group in Japan, recently received ISO13485:2003 certification for the production and sales of In Vitro Diagnostic (IVD) GMP-grade oligonucleotides.
ISO13485 is recognized as the global standard for quality management systems relating to the design, development, production, installation and servicing of medical devices.
“Nippon EGT supplies molecular diagnostics manufacturers and clinical testing laboratories with highly reliable and traceable IVD oligonucleotides which are controlled by the rigorous quality management system based on ISO13485,” said Dr. Yuko Yoneda, President of Nippon EGT. “Nippon EGT aims to be a leading supplier of IVD oligonucleotides in Japanese and Asian molecular diagnostics markets.”
“The Japanese ISO13485 certification completes yet another important milestone in Eurogentec’s strategy to further grow our presence in the global molecular diagnostics markets as a preferred supplier of IVD GMP assay components,” says Dr. Peter Haima, Eurogentec’s Director for Diagnostic Services. “This rigorous medical device quality system certification provides added assurance to our clients in Asia that Eurogentec has established highly reliable, effective and reproducible processes for manufacturing of oligonucleotides used in molecular diagnostic devices and Lab Developed Tests (LDTs). In June this year we also plan to complete ISO13485 certification for our GMP/QSR compliant clean room oligo production facility in North America. With three fully harmonized ISO13485-certified facilities in Europe, North America and Japan we are able to offer our diagnostic clients uninterrupted supply of Diagnostic GMP oligos.”
ABOUT EUROGENTEC
Eurogentec 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. Eurogentec S.A. provides a wide range of expertize in small- and large-scale DNA, RNA, peptide synthesis and antibody supply. Eurogentec is also an experienced Contract Manufacturing organization (CMO), operating a state-of-the-art GMP/QSR compliant and ISO13485:2003 certified oligonucleotide manufacturing facility in Belgium. The Belgium manufacturing facility for IVD oligos is complemented by additional production facilities in North America and Japan. The North American facility is on schedule to be ISO13485 certified and fully GMP/QSR compliant by June 2010. Eurogentec is also an experienced Contract Manufacturing Organization (CMO) for Biopharmaceuticals, operating a full-service, state-of-the-art GMP facility in Belgium.
