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Oligonucleotides for Use in IVD or Molecular Diagnostics
Transitioning oligonucleotides from research to in vitro diagnostics (IVD) applications, which means that reagent quality may have an influence on critical medical decisions involves much more than merely trying to figure 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 that are manufactured under controlled processes.
- Final yields up to several thousand nmol.
- Comprehensive batch records
- Continuous risk management process
- Tech transfer is possible during any phase of product development.
- Stringent product release criteria
- The oligonucleotide production facilities of Microsynth are both EN ISO 9001:2015 and EN ISO 13485:2016 certified.
- We assign you a dedicated expert contact person to provide consultation on all aspects of the manufacturing and regulatory compliance.
- We provide regular status updates.
- Customized manufacturing processes (synthesis scale, purification, formulation, and QC) as well as documentation across all development phases.
The following figure outlines the various process steps that are typically required to produce oligonucleotides for use in IVD or molecular diagnostics, as well as Microsynth's integrated service offering.