International Introduction of GMP Oligonucleotides for IVD and ASR Applications by Eurofins Genomics
Eurofins Genomics has introduced its good manufacturing practices (GMP) oligonucleotide offerings across Europe for in-vitro diagnostic and analytic specific reagents (ASR) applications within the pharmaceutical industry.
Eurofins Genomics introduced cGMP products in the Americas. The growing demand in for these products and services led to the roll-out of GMP sales and service support in Europe.
Regulatory requirements must adhere to highly standardised process controls. They are applied during early stages of research and development and through the commercialisation of products and services.
Eurofins Genomics wants to offer customised cGMP services that are handled by specialists to support full commercialisation from pilot projects through to 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.
The company is internationally recognised by the ISO: 13485 certification and FDA cGMP registration.
Eurofins Genomics Europe general manager Peter Persigehl said: "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."