Eurogentec Launches new Oligo Synthesis Facility
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Eurogentec S.A., an established European supplier of custom oligonucleotides, peptides and specialty reagents to the life science markets, announces the opening of a new North American manufacturing facility located in San Diego, California.
“This new facility is a key component of the strategic plan for Eurogentec to grow its global business in the life science research, molecular diagnostic, and clinical laboratory markets,” stated Diane Wolfe, General Manager of Eurogentec North America. “Our goal now is to directly serve the North American market by producing the same high-quality, custom oligos that Eurogentec S.A. has supplied to the US and Canada for the past seven years.”
The San Diego production site, already ISO 9001 certified for the manufacture of research-grade oligonucleotides, will be in compliance with ISO 13485:2003 and the cGMP statutes detailed in 21 CFR Part 820 by the end of 2009. “Our intent is to harmonize processes between our US facility and the European manufacturing site, which is already ISO 13485 certified,” remarked Ms. Wolfe.
In addition, Jean-Pierre Delwart, CEO of Eurogentec, commented that “the facility’s state-of-the-art instrumentation for multi-scale oligonucleotide synthesis, purification and quality control position Eurogentec North America to meet the rapidly growing needs of life scientists. Our markets include academic, biotech, pharmaceutical, agricultural, veterinary, bio-defense, diagnostic and clinical laboratories. In addition, a suite of segregated, limited access Class 100,000 clean rooms will allow us to meet the growing demand for GMP-compliant custom oligonucleotides for ASRs, LDTs and in vitro diagnostic applications.”
Eurogentec North America will be announcing the opening of its new facility at the upcoming TIDES (Oligonucleotide and Peptide) 2009 Conference in Las Vegas. An evening reception is planned for May18th in the Veranda Room at the Red Rock Casino, Resort & Spa. Guests will have the opportunity to meet with Jean-Pierre Delwart, Peter Haima (Director, IVD Services), Diane Wolfe and members of the Eurogentec North American team.
“This new facility is a key component of the strategic plan for Eurogentec to grow its global business in the life science research, molecular diagnostic, and clinical laboratory markets,” stated Diane Wolfe, General Manager of Eurogentec North America. “Our goal now is to directly serve the North American market by producing the same high-quality, custom oligos that Eurogentec S.A. has supplied to the US and Canada for the past seven years.”
The San Diego production site, already ISO 9001 certified for the manufacture of research-grade oligonucleotides, will be in compliance with ISO 13485:2003 and the cGMP statutes detailed in 21 CFR Part 820 by the end of 2009. “Our intent is to harmonize processes between our US facility and the European manufacturing site, which is already ISO 13485 certified,” remarked Ms. Wolfe.
In addition, Jean-Pierre Delwart, CEO of Eurogentec, commented that “the facility’s state-of-the-art instrumentation for multi-scale oligonucleotide synthesis, purification and quality control position Eurogentec North America to meet the rapidly growing needs of life scientists. Our markets include academic, biotech, pharmaceutical, agricultural, veterinary, bio-defense, diagnostic and clinical laboratories. In addition, a suite of segregated, limited access Class 100,000 clean rooms will allow us to meet the growing demand for GMP-compliant custom oligonucleotides for ASRs, LDTs and in vitro diagnostic applications.”
Eurogentec North America will be announcing the opening of its new facility at the upcoming TIDES (Oligonucleotide and Peptide) 2009 Conference in Las Vegas. An evening reception is planned for May18th in the Veranda Room at the Red Rock Casino, Resort & Spa. Guests will have the opportunity to meet with Jean-Pierre Delwart, Peter Haima (Director, IVD Services), Diane Wolfe and members of the Eurogentec North American team.
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