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GMP Manufacturing Services

Photos of TriLink facility and lab personnel in full gown using a pipette.

TriLink operates a state-of-the-art Current Good Manufacturing Practice (cGMP) production facility. As the leading manufacturer of mRNA, nucleotides, nucleoside triphosphates, and oligos, our unparalleled experience, technical expertise, and scalability make us an ideal partner for clinical or preclinical projects. TriLink can support your project from the initial research phases to the production of APIs for use in clinical trials.

The TriLink Quality System:

  • Meets ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 19, APIs for use in clinical trials
  • Certified ISO 9001:2015
  • Practices continual improvement

Our manufacturing processes are fully customizable and scalable to support your needs for discovery, preclinical, and clinical projects. Our cGMP suites and labs are designed to support multiple stages of clinical development. Additionally, cGMP suites can be utilized for manufacturing reagents for diagnostic applications.

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Chart to show differences and similarities between research, GMPlink, and GMP grades of manufacturing.

Manufacturing Flexibility

We understand that manufacturing needs are not one size fits all. That is why we offer a range of manufacturing grades - from small to large scale research use only (RUO), to intermediate GMPLink services, and full GMP. TriLink has the protocols in place to manufacture and scale up the following product categories as RUO, GMPLink, and GMP-grade materials:

  • mRNA, CleanCap®, long RNA, CRISPR guide strands (sgRNA), oligonucleotides, nucleotides and nucleosides, aptamers, plasmids
  • Contact us to initiate your custom build
Photo of GMP lab with technician working within the glove box isolator.

State-of-the-Art Facility

Our 118,000 square foot custom built TriLink headquarters in San Diego, California includes dedicated manufacturing space designed for flexibility of scale. The cGMP suites include routine monitoring of temperature, pressure, humidity, and particle count. Suites have ISO Class 5 fill finish isolators and a single-pass HEPA-filtered air system. Virtual and onsite site tours are available for audit ease and accessibility. Our facility is supported by comprehensive quality programs and quality systems.

Our facility operates:

  • Four ISO Class 7 clean room
  • Eleven ISO Class 8 clean rooms
  • Two analytical and functional support laboratories to support product testing

Getting Started with TriLink GMP Manufacturing

TriLink has the manufacturing capacity, quality systems, and technical support to successfully progress your project toward clinical application. To initiate a project, please contact us for an intake meeting, in which we will discuss your project, expectations, and timelines.

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Learn More About Reagent Manufacturing for Diagnostic Applications

TriLink manufacturing includes fully traceable batch records, rigorous analytical QCs, QA product release, and a signed Certificate of Analysis - the complete package for your diagnostic application.

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