Certification underlines AROS’ strength for NGS services within the regulatory field.
AROS, a member of the Eurofins Genomics Group, has now extended their Good Laboratory Practice (GLP) certification for Next Generation Sequencing (NGS) services.
Good Laboratory Practice is a required standard for laboratories conducting non-clinical safety studies, for example pharmacology and toxicological studies. It is also required for non-clinical safety studies for the development of drugs, small molecules, vaccines and gene therapeutics. GLP standards are also critical for the development of diagnostic kits and device validation (FDA and patent submissions).
AROS have been GLP certified by the Danish Health Authorities since 2005 for their DNA and RNA extraction services, qPCR (Gene Expression and Genotyping) and microarrays (Illumina and Affymetrix). In 2015 they have added the certificate “non-clinical safety studies for medical products on NGS under GLP” to their GLP certified platforms. With this certificate, AROS offers GLP services for the “lllumina TruSeq stranded mRNA” and the “Illumina HiSeq v4 sequencing” protocols. Further GLP certified NGS Illumina sequencing applications will follow soon.
“The GLP certification for NGS is one of the highest QM/QA certifications that can be achieved for non-clinical analyses. We are very proud to strengthen our footprint as the genomic solution provider for pharma & diagnostics in Europe,” says Morten Melbye, CEO AROS Applied Biotechnology and General Manager Pharmaceuticals Eurofins Genomics. “The GLP certification reflects the combined result of our highly qualified people, formal quality management and quality assurance systems, long-term experience and our continued focus on quality.”
“The Eurofins Genomics Group including AROS is excellently positioned in the field of fast developing Next Generation Sequencing technologies. With the GLP certification the companies are ready to provide services with the highest demand of regulatory authorities to serve the Pharma market,” says Bruno Poddevin, Senior Vice President Eurofins Genomics.