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Oligonucleotides for Use in IVD or Molecular Diagnostics
Transitioning oligonucleotides from research to in vitro diagnostics (IVD) applications —where reagent quality may have an influence on critical medical decisions — involves a lot more than figuring out how to scale up production.With over 30 years of experience in oligonucleotide synthesis and nucleic acid analytics, Microsynth has established itself as a reliable business partner for contract manufacturing of oligo components for in vitro diagnostic suppliers. Our state-of-the-art production facilities, superior quality reagents, stringent quality standards, and fully customizable manufacturing processes make Microsynth the partner of choice for diagnostic test manufacturers.
Features and Benefits
- All phases of product development are covered; custom-synthesized oligos for research, oligos for pilot diagnostic testing or even oligos for molecular diagnostic assays manufactured under controlled processes.
- Final yields up to several 1000 nmol
- Comprehensive batch records
- Continuous risk management process
- Tech transfer possible at any product development phase
- Stringent product release criteria
- The oligonucleotide production facilities of Microsynth are EN ISO 9001:2015 and EN ISO 13485:2016 certified.
- We assign you with a dedicated expert contact person to provide consultation on all aspects of manufacturing and regulatory compliance
- We provide regular status updates
- Customized manufacturing processes (synthesis scale, purification, formulation, QC) as well as documentation across all phases of development
The following figure shows the various process steps typically required to produce oligonucleotides for use in IVD or molecular diagnostics, and Microsynth's integrated service offering.