A unique provider for your oligonucleotides

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.

GMP Certified Oligos

We received our GMP Certificate from Belgian Health Authorities to produce Oligonucleotides intended for phase I clinical trials.

We are ready to support you in your therapeutic project

Pre-clinical oligos

We manufacture pre-clinical oligonucleotides using scalable synthesis and purification methods.

The pre-clinical oligonucleotides include :

  • Appropriate QCs and additional controls according to your needs
  • Detailed Certificate of Analysis
  • Manufacturing Record Summary as support to complete the CMC module for IND/IMPD files

GMP Therapeutic oligos

We manufacture oligonucleotides of high and reproducible quality in accordance with GMP therapeutic requirements.

We produce all the oligonucleotides in classified cleanrooms and optimize the synthesis, purification methods and downstream processes. Any oligonucleotide backbone can be conjugated to different molecules such as Cholesterol or PEG to help Drug Substance delivery, stability and efficiency.

Analytical services

QC analytical methods are qualified for raw material and final product release to meet your specifications.

  • Appearance, pH, Osmolality,
  • Purity by UPLC / HPLC, Bioburden, Endotoxin level,
  • Identity by Mass Spectrometry (ESI), Sequencing,
  • Stability studies
  • Residual solvents, Residual heavy metals, Water content, Sodium content,
  • Phosphorothioate - Phosphate content

Quality & Regulatory support

QA representatives supervise all projects.

Manufacturing is recorded in Batch Records. A full Manufacturing Record Summary is provided to complete the Chemistry, Manufacturing and Controls (CMC) module for IND/IMPD files.

We offer support in the writing and review of CMC quality module documentation.

Benefit from the Eurogentec's expertise

+

Years of experience


High quality oligonucleotides
for research, commercial and diagnostic fields

+

Years of experience


Injectable GMP manufacturing
of proteins and plasmid DNA for pharma companies

+

Years of experience


Multi-grams oligonucleotides synthesis
and purification for pre-clinical market

A continuous follow-up all along your project

We assist our customers from the first contact to the release of the drug substance.

A Project Manager is assigned to each project to give you advices, manage communication between you
and the Eurogentec's production team and ensure the project runs smoothly.

Talk to a specialist

Collaboration steps

  1. Introduce the business

    First Contact - Introduction with our specialists - Confidential disclosure agreement (CDA) allowing two-way exchange of information .

  2. Collaboration Offer

    Project Evaluation - Quotation - Master Supply / Project Agreement - Quality Agreement

  3. GMP Manufacturing

    Project Start - Production - Drug Substance Release


    Get a quote