International Roll-Out of GMP Oligonucleotides for IVD and ASR Applications by Eurofins Genomics

Eurofins Genomics, the genomics division of the Eurofins Scientific Group and market leader in DNA synthesis, has rolled out its Good Manufacturing Practices (GMP) oligonucleotide offerings across Europe to meet the growing demand of cGMP manufacturing for IVD (in vitro diagnostic) and ASR (analytic specific reagents) applications within the clinical, pharmaceutical, food safety and animal health market.

Eurofins Genomics recently introduced cGMP products in the Americas. The growing demand in Europe for these type of products and services led to the roll-out of the GMP sales and service support in Europe. Regulatory requirements must adhere to highly standardised process controls. They are applied during the early stages of research and development and through the commercialisation of products and services. Eurofins Genomics wants to meet this demand by offering customised cGMP services that are handled through specialists to support full commercialisation - from pilot projects through to the manufacturing of small and large scale cGMP oligonucleotides which require regulatory documentation. In addition, Eurofins Genomics supports cGMP ASR manufacturing and testing for genomic platforms.

Eurofins Genomics is internationally recognised by the ISO 13485 certification and FDA cGMP registration.

“We have seen a large increase in requests for GMP compliant services from our international customer base. With the offering of custom cGMP oligonucleotides, customers have streamlined access to dedicated products with highly standardised process controls, documentation and a map of expected milestones," says Peter Persigehl, General Manager Eurofins Genomics Europe.