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Pre Clinical Oligonucleotides

With over 25 years experience, Eurogentec [part of Kaneka Corporation] is a leading supplier of high-quality reagents for the Life Science Community, Diagnostic and Pharmaceutical Industries. We offer a wide range of GMP oligonucleotide-based components for Molecular Diagnostic [Dx] applications. This level of GMP expertise is also fully adaptable to preclinical studies.
Eurogentec’s Quality Management System [QMS] is compliant with the cGMP Quality System Regulation [QSR] and ISO 13485 certified for oligonucleotide production.

Our state-of-the-art cleanroom facilities meet Class 100,000 [ISO 8] and Class 10,000 [ISO 7] standards with Class 100 [ISO 5] working zones:

  • Controlled key card access
  • Strict gowning policy
  • Full segregation of synthesis, cleavage/deprotection, purification and fill & finish processes

 

Synthesis

μg, mg and multi-grams
Backbones: DNA, RNA, LNA®, 2’O-Me RNA Phosphorothioate...

Modifications

>250 modifications: including Amine, Thiol, Biotin, Cholesteryl, PEG, Fluorescent dyes...

Purifications

RP and IE-HPLC (single or dual)

QC Methods

MS, RP or IE-HPLC, CGE
Validated QC methods

Additional Services

Sterile filtration
Optional testing: bioburden, endotoxin, residual solvents, heavy metals
Custom formulation

Pre-Clinical oligonucleotides process/service includes

Classified cleanroom manufacturing environment / Comprehensive batch record / Stringent product release QC criteria / Detailed CoA / Dedicated account contact person


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