From research to commercialization
Pre-diagnostic & Diagnostic Oligonucleotides
We manufacture custom oligos for in vitro diagnostics and commercial use in controlled environment.
Our manufacturing site located in Belgium is equipped with cleanrooms that meet ISO7 and ISO8 standards to prevent contamination.
We manufacture Pre-Diagnostic and Diagnostic grade oligonucleotides under a QMS which is ISO 13485 certified (ISO 13485 is equivalent to 21 CFR part 820 and is recognized by the FDA).
Our oligos accompany you
from research to commercialization
We have a strong background in the synthesis of primers and probes for clinical diagnostics and offer a good continuum from research to commercialization.
Our experts work in state-of-the-art facilities to deliver high-quality oligonucleotides in accordance with the customer’s request.
Each oligo grade is accompanied with the appropriate documentation according to its usage.
|Dedicated Account Contact Person||Option||✓||✓||✓|
|Customized Fill & Finish||Option||Option||✓||✓|
|ISO 9001 Certified Process||✓||✓||✓||✓|
|ISO 13845 Certified Process||-||-||✓||✓|
|Qualification/Validation [Equipment & Method]||-||Partial||✓||✓|
|Stringent QC Tests [validated]||-||✓||✓||✓|
|Batch Record [Archived for 5 years]||-||-||Partial||Full|
|Certificate of Analysis [CoA]||-||✓||✓||✓|
GMP oligonucleotide manufacturing
for molecular diagnostics
We offer a broad expertise in the production of critical oligonucleotide components for molecular diagnostic assays and diagnostic kit manufacturing.
- We produce molecular diagnostic oligos from small to large scales.
- Various modifications are available with IP-friendly fluorescent Dyes and Quenchers incl BHQ® and EDQ-MGB.
- We can adapt and customize our MDx oligo manufacturing [synthesis scale, purification, fill & finish, QC].
- We offer IVD Oligo manufacturing with custom formulation and packaging.
- We have been manufacturing custom Oligonucleotides since 1985
- We have a strong expertise in complex IVD oligo manufacturing
- Our certified clean-rooms are equipped with state-of-the-art material
- Our employees are trained to operate in GMP environment
- We are ISO 13485 Certified
- We produce oligos for IVD in classified cleanrooms
- Continuous risk management process
- Stringent product release QC criteria
- Comprehensive internal batch records
A dedicated account manager is assigned to each project.
We encourage regular discussions to ensure clear understanding of manufacturing requirements and specifications. In addition, our technical experts are available for consultation on all aspects of manufacturing and quality system.
Each Step of the process
- Synthesis scale from μg to multi-grams
- Dedicated equipment and reagents
- Development of custom modifications
- Custom mixes of backbones
- Ion Exchange UHPLC (IEX-UHPLC)
- Reverse-Phase UHPLC (RP-UHPLC)
- Dual UHPLC
- Ultrafiltration [Large scale only]
- Dedicated purification columns available
- Typical QC Release Methods
- Quantification (UV spectrophotometry)
- Physical inspection
- Mass Spectrometry : ESI-TOF, MALDI-TOF, LC-MS
- Ion Exchange UHPLC (IE-UHPLC)
- Reverse-Phase UHPLC (RP-UHPLC)
- 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
What you get
We are an oligonucleotide component manufacturer for diagnostic assays. We provide MDx oligos to clinical labs, diagnostic companies and IVD kit manufacturers.
Partnering with us means that you will receive a GMP-IVD grade Quality Product.
You have the guarantee of a full controlled process, traceability and consistent lot-to-lot reproducibility.
Custom oligos for in vitro diagnostics are manufactured in cleanrooms with very low risk of contamination.
You benefit from a continuous project oversight and a real-time status update.
Quality Management System
As required by the ISO 13485 standard, we have implemented a comprehensive risk management system based on the FMEA (Failure Mode and Effects Analysis) to identify possible failure modes, determine their potential effect(s) on product manufacturing and identify actions to mitigate those failures.