GMP Oligonucleotides for IVD and ASR Applications

Custom cGMP services with highly standardised process controls to support pharmaceutical drug development process as it advances through clinical trials and on to commercial production.

Carola Grimminger, Marketing Manager Eurofins Genomics, carolagrimminger@eurofins.com

Regulatory requirements must adhere to highly standardised process controls along the product development cycle. They are applied during discovery, development and through the commercialisation of products and services.

Especially the GMP (Good Manufacturing Practice) standard is required to be adapted in pharmaceutical manufacturing. It is the highest quality standard that can be achieved for the production and testing under this level of manufacturing.

During the past years since the FDA approved the first oligonucleotide-based therapeutic, compounds based on synthetic oligos have  established themselves as critically important tools for life scientists. A growing number of companies are developing oligonucleotide-based pharmaceutical products, which are in various stages of pre-clinical testing. As a result of this increasing activity, the requirement for GMP  manufactured synthetic oligonucleotides for pre-clinical testing and eventual in vivo use becomes increasingly important. The DNA and RNA oligonucleotide synthesis has gained industry importance with proven therapeutic and molecular diagnostic (Dx) applications. To meet the  growing demand of cGMP manufacturing for IVD (in vitro diagnostic) and ASR (analytic specific reagents) for laboratory developed tests (LDTs) within the pharmaceutical market, Eurofins Genomics offers a new oligonucleotide process control.

As a global leader in a wide range of genomics products and services, Eurofins Genomics introduced cGMP products to support clients'  needs - from pilot projects through to the manufacturing of small and large scale cGMP oligonucleotides, which require regulatory  documentation.

The company is internationally recognised by the ISO 9001, ISO 13485 certification and FDA cGMP registration for use in IVD products. Through continuous risk management processes, comprehensive batch records, traceability and dedicated account contact persons, clients have streamlined access to products with highly standardised process controls, documentation and a map of expected milestones.

Eurofins Genomics is flexible and committed to provide cost-efficient client solutions for their pharmaceutical drug development programme. 

For more information, visit:www.eurofinsgenomics.eu