Signature Quality TriLink is an industry leader in manufacturing high quality oligonucleotides and nucleoside triphosphates at small and mid-scales. We operate a GMP laboratory with a QSR environment. We believe it is our responsibility to work with our customers to push past technical barriers and create the programs they need. Our product management, manufacturing and quality assurance teams work together to understand the challenges of each synthesis and develop the best possible products.
Quality Policy
TriLink aims to exceed our customer's expectations by maintaining the highest level of quality and service.
Quality Assurance
All TriLink products undergo final analytical testing, typically a PAGE and MS analysis, to ensure the product meets our release specifications. The QC analyses are then incorporated in the certificate of analysis provided with each product. Every TriLink product and certificate of analysis is reviewed by a Quality Assurance Specialist and verified to be correct before shipment.
QSR and cGMP Manufacturing
TriLink will work with you to develop, document and validate processes and materials for your specific product needs. We will then manufacture your product under a quality system based on the FDA's Quality System Regulations (QSR) and the ISO 9001:2008 standard. We also offer programs compliant with the FDA 21CFR 820 regulation for ASR manufacture.
Benefits of Manufacturing under QSR:
- Multi-gram batches
- Lot to lot consistency
- Optimized purification protocols
- Ultra-filtration desalting available
Program Guidelines Include:
- All personnel trained in QSR compliance
- SOPs & central records handling
- Supplier validation & traceable raw material
- Controlled access to dedicated laboratories Please contact us to discuss your specific manufacturing needs.
