A continuum from research
to commercialization

Our offer covers all phases of Molecular Diagnostic
assay development from R&D to commercialization.

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Oligonucleotide Grades Research Track™ Pre-Diagnostic Diagnostic
Process        
Dedicated Account Contact Person Option ✓ ✓ ✓
Customized Fill & Finish Option Option ✓ ✓
Quality Management        
ISO 9001 Certified Process ✓ ✓ ✓ ✓
ISO 13485 Certified Process - - ✓ ✓
Qualification/Validation [Equipment & Method] - Partial ✓ ✓
Control        
Quantification Single Dual Triple Triple
Stringent QC Tests [validated] - ✓ ✓ ✓
Traceability Partial Documented Documented Full Documented
Batch Record [Archived for 5 years] - - Partial Full
Classified Cleanroom - - ✓ ✓
Certificate of Analysis [CoA] - ✓ ✓ ✓

Increased Traceability

The traceability built into our Track™ Oligonucleotide manufacturing process is well suited for most molecular diagnostic applications :

  • clinical & hospital lab services
  • companies developing IVD assays & kits
  • other lab service industries (Food & Water Safety Testing, Environmental Testing, Veterinary Diagnostics, Biodefense...).

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Specifications

  • Custom Backbones :
    DNA
    RNA

  • Modifications :
    >250 Modifications available incl. proprietary dyes (HiLyte™) and quenchers (QXL™)

  • Purification Methods :
    RP/IEX HPLC [Single or Dual]

  • QC Validated Methods :
    MS and HPLC
    Additional QC on request

  • Optional Services:
    Aliquoting