cGMP Manufacturing Services

We've combined our expertise in nucleic acids with a state-of-the-art Current Good Manufacturing Practice (cGMP) production facility. TriLink offers cGMP manufacturing for discovery through early phase clinical trials for therapeutic and diagnostic applications. With nine dedicated manufacturing suites and two support labs, TriLink can support your project from the initial research phases to the production of APIs for use in clinical trials.

TriLink operates a quality system that meets ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 19, APIs for use in clinical trials. We are ISO 9001:2015 certified and practice continual improvement.

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cGMP Manufacturing for Therapeutics

TriLink can take you through research, process development synthesis, and into the clinic with our cGMP manufacturing for therapeutic applications.

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Manufacturing for Diagnostics

TriLink manufacturing includes fully traceable batch records, rigorous analytical QCs, QA product release, and a signed Certificate of Analysis perfect for your diagnostic test raw material. 

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