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GMP Oligonucleotide Manufacturing

With over 25 years experience in oligonucleotide manufacturing, Eurogentec provides exceptional quality products. The wide range of oligonucleotides proposed is suitable from research to commercialization. All oligonucleotides are manufactured by fully trained and skilled chemists in an appropriate environment.
We encourage regular face-to-face meetings or online teleconferences to ensure clear understanding of manufacturing requirements and specifications. In addition, our technical experts are available for consultation on all aspects of manufacturing and regulatory compliance.

Benefits Features
Regulatory compliance FDA 21 CFR 820 Compliant & ISO 13485 Certified
Contamination mitigation Classified cleanroom manufacturing environment
Matigate manufacturing errors Continuous risk management process
Consistent lot-to-lot reproducibility Stringent product release QC criteria
Flexibility Customized processes [synthesis scale, purification, fill & finish, QC]
Cost-effective client solution Appropriate grades following phases of development
Full process traceability Comprehensive batch records
Continuous project oversight and real-time status updates Dedicated account contact person

Documentation requirements differ significantly as oligonucleotides progress from Discovery and Feasibility to Validation and Commercialization. Eurogentec partners choose from three progressively detailed levels of documentation and overall quality assurance appropriate for each phase of product development and commercialization.

  > Synthesis scale from μg to multi-grams
> Dedicated equipment and reagents
> Development of custom modifications
> Custom mixes of backbones
> Ion Exchange UHPLC (IE-UHPLC)
> Reverse-Phase UHPLC (RP-UHPLC)
> Dual UHPLC
> PAGE [Research grade only]
> Ultrafiltration [Large scale only]
> Dedicated purification columns available
Typical QC Release Methods
> Final mass (μmol, μg, OD)
> Physical inspection
> MALDI-TOF, ESI- and LC-Mass Spectrometry
> Ion Exchange UHPLC (IE-UHPLC)
> Reverse-Phase UHPLC (RP-UHPLC)
> Capillary Gel Electrophoresis (CGE)
Optional QC Release Methods
Customized QC Release Methods
Product Stability Testing
> Customized mixtures of individual oligonucleotides
> Conjugated oligonucleotides (HRP, AP, synthetic peptides, proteins)
> Lyophilized, dried or in solution (H2O, Tris Buffer or custom Buffer)
> Bulk or aliquoted into tubes or plates
> Customized fill & finish
> Customized packaging and labeling

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