EUROGENTEC recently announced that it is making a significant capital investment to expand its current GMP oligonucleotide manufacturing facility in Liege, 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.
According to EUROGENTEC, in order to fully meet this rapidly growing demand, the new facility and quality management systems will be fully compliant with the ISO13485:2003 quality standard and FDA’s 21 CFR 820.
Upon completion, the expanded facilities will incorporate a strict card key access and airlock pass-through and gowning policy for all employees and permit full segregation of all critical manufacturing steps utilizing clean rooms of various classes. The expansion is scheduled to be completed by January 2008.
EUROGENTEC also announced plans 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 US–based diagnostic companies’ rapidly increasing need for GMP oligos.
In particular, 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.