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
μg, mg and multi-grams
Backbones: DNA, RNA, LNA®, 2’O-Me RNA Phosphorothioate...
>250 modifications: including Amine, Thiol, Biotin, Cholesteryl, PEG, Fluorescent dyes...
RP and IE-HPLC (single or dual)
MS, RP or IE-HPLC, CGE
Validated QC methods
Optional testing: bioburden, endotoxin, residual solvents, heavy metals
|Pre-Clinical oligonucleotides process/service includes
Classified cleanroom manufacturing environment / Comprehensive batch record / Stringent product release QC criteria / Detailed CoA / Dedicated account contact person