EUROGENTEC CEO Jean-Pierre Delwart cut the ribbon officially opening a new facility for IVD GMP oligonucleotide manufacturing in Liège, Belgium. The rapidly growing Molecular Diagnostic and in vitro Diagnostic markets have exceptionally stringent oligonucleotide manufacturing requirements as codified by the European IVD directive 98/79 EEC and U.S. FDA’s 21 CFR 820 GMP statutes. In order to fully meet this rapidly growing demand, the new facility and quality management systems are fully compliant with the ISO13485:2003 quality standard and FDA’s 21 CFR 820. The expanded facilities incorporate a strict card key access, airlock pass-through and gowning policies for all employees, permitting full segregation of all critical manufacturing steps utilizing clean rooms of various classes (Class 100,000 and 10,000 rooms with Class 100 working zones). ISO13485 certification is planned for Q4 2008.
EUROGENTEC’s board also approved significant capital investment to expand and enhance its oligonucleotide manufacturing facilities in the USA. The new US facilities will be similar to the European GMP facility, allowing EUROGENTEC to address its increasing base of US diagnostic customers’ need for IVD GMP oligos. The new US facility is based in San Diego, California and is expected to be operational as of Q3/4 2008. Full compliance to FDA’s 21 CFR 820 and ISO 13485 certification is planned for 2009.
EUROGENTEC’s unique multi-site manufacturing capabilities in Europe, the United States, Japan and Singapore will ensure B2B customers an uninterrupted supply of high quality R&D and GMP-level assay components for their IVD products.
CEO Jean-Pierre Delwart commented: “This expansion demonstrates EUROGENTEC’s increasing commitment to the Molecular Diagnostic and in vitro Diagnostic markets. EUROGENTEC has been a leading supplier of high quality oligos, antibodies and research products to scientists and B2B customers for 20 years and a supplier of GMP-compliant oligos and antibodies since 2004. However, the increasing demand for GMP oligos requires us to expand our manufacturing facilities and processes to fully meet the highest quality guidelines as set forth by European and US regulations. With the completed expansion of our Belgian and US GMP facilities, EUROGENTEC will significantly strengthen its position as a leading provider of GMP oligos to the IVD industry.”
About EUROGENTEC
From its global headquarters in Liège, Belgium, EUROGENTEC has been a leading provider of innovative products and services to the Life Science, Diagnostic and Pharmaceutical communities for over 20 years. The company has distribution networks in over 40 countries and employs more than 300 people worldwide. The main cGMP oligo production site in Belgium is complemented by additional production facilities in the USA, Japan and Singapore providing B2B customers with overlapping manufacturing capabilities and harmonized methods, procedures and Quality Management Systems. In addition to GMP diagnostic oligonucleotide and antibody production, the parent company operates an authorized facility for the GMP manufacturing of biologics.
For more information
EUROPE • Dr. Peter Haima • Tel.: + 32 4 372 76 35 • Fax: + 32 4 372 75 00 • p.haima@eurogentec.com • Liège Science Park • 4102 Seraing • Belgium
NORTH AMERICA • Mr. Harrison Ransom • Tel.: + 1 858 793 2661 • Fax: + 1 415 680 1686 • h.ransom@eurogentec.com • 3347 Industrial Ct., Suite A • San Diego • CA 92121-1031
