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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

 
 
Scalability
  • 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

 

Services

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.