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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 25 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 laboratories, 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.
- Bulk production up to 10 g possible
Full process traceability and risk mitigation
- Comprehensive batch records
- Continuous risk management process
- Tech transfer possible at any product development phase
Consistent lot-to-lot reproducibility
- Stringent product release criteria
Professional project management
- Dedicated expert contact person for consultation on all aspects of manufacturing and regulatory compliance
- Regular status updates
Cost-effective and customized client solution
- Customized manufacturing processes (synthesis scale, purification, formulation, QC) as well as documentation across all phases of development
Get a Quote
When you collaborate with Microsynth, we share our experience and knowledge, respond to your needs in a timely manner and give you undivided attention. Interested to discuss your contract manufacturing need with an expert or to receive a quote? Then, please fill in our contact form.