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Therapeutic Oligos

Therapeutic Oligos

High quality DNA and RNA oligonucleotide synthesis

Eurogentec provides custom DNA and RNA oligonucleotides for various applications.

Oligonucleotides are manufactured in dedicated facilities according to their grade. Hence preclinical and GMP therapeutic oligonucleotides are produced in ISO 7 & 8 classified cleanrooms repsectively.

Our extensive and technical expertise allow us to offer a broad range of chemistries and modifications. We are able to produce different types of oligonucleotides including siRNA, Antisense, Aptamer, CpG among others.

Pressure control panel of the Iso7-8
cleanroom


A unique provider for your oligonucleotides
from discovery to early clinical phases

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.



Oligonucleotides production from discovery to early clinical phases


Pre-clinical Oligonucleotides

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


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GMP Therapeutic Oligonucleotides

Our rigourous Quality System, the production under classified cleanrooms as well as the optimization of purification and downstream processes allow us to produce oligonucleotides of high and reproducible quality in accordance with GMP therapeutic current requirements.

Any oligonucleotide backbone can be conjugated to different molecules such as Cholesterol or PEG to help drug delivery, stability and efficiency.



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Analytical services

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

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

Please contact us for additional QC

Quality & Regulatory support

Our Quality Unit is based on 3 departments:

  • Quality Assurance (QA) (Regulatory support)
  • Quality Control (QC)
  • Validation / Metrology

QA release of the Drug Substance is done according to specifications established between Eurogentec and the customer.

It is documented in a full Batch Record containing all production and analytical steps. We offer support in the writing and review of Chemistry, Manufacturing and Controls (CMC) quality module documentation in CTD for the submission of IND or IMPD files.

QA representatives supervise all projects regarding respect of appropriate regulatory and quality instructions.

Therapeutic Oligo quality & regulatory support

Working with Eurogentec



Therapeutic oligos project management
30 years of
experience
high quality oligonucleotides
for research, commercial and
diagnostic field
 
15 years of
experience
multi-grams oligonucleotides
synthesis and purification for
pre-clinical market
 
20 years of
experience
injectable GMP manufacturing
of protein and plasmid DNA for
pharma companies
 


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