ISO 8 & 7 classified cleanrooms에서 생산되는 Pre-clinical & Clinical Oligonucleotides를 소개합니다.
GMP Certified Oligos:
GMP accreditation* by the Belgium Authorities for the manufacturing and quality control of therapeutic oligonucleotides according to ICH Q7. (* Accreditation Q1 2019)
Eurogentec accompanies you from your research to your clinical trials (Phase 1 and 2). Each oligo is synthesized with the appropriate grade corresponding to its application.
QC analytical methods are qualified for raw material and final product release to meet your specifications.
• Purity by UPLC / HPLC
• Identity by Mass Spectrometry (ESI)
• Endotoxin level
• Residual solvents
• Residual heavy metals
• Sodium content
• Phosphorothioate – Phosphate content
• Water content