Manufacturing for IVD and Molecular Diagnostics

TriLink manufactures reagents as a key supplier for components in your diagnostic application. We understand that diagnostic medical device technologies require diverse modifications at different scales of synthesis. TriLink is your partner from research to the clinic, with decades of expert experience to understand your commercialization needs. 

Our expertise and extensive selection of modifications and conjugates ensure that we can meet your molecular diagnostic synthesis requirements. We offer flexible customization and expert consultation with over 20 years of in-house manufacturing experience. We can do this at all stages of your product development project, at the scale and purity to fit your commercial needs.

The TriLink OEM program also includes diagnostic grade cGMP manufacturing.

TriLink understands that your program does not have fixed needs. We have a dedicated support team available to guide you on a path of optimal cost savings and efficiency, tailored to the needs of each phase of design and development. 

Inquire about Diagnostic Manufacturing

Quality

Quality is at the core of all we do at TriLink. We operate our facility under ISO 9001 certified Quality Management System, and can offer reagents which are fully compliant with ICH Q7, Section 19, as needed by the customer.

Whether your diagnostic test is a PMA, a 510k or is regulated as a LDT under CLIA, TriLink cGMP includes preparation of oligos with a fully traceable batch record, rigorous analytical QC, QA product release, and a signed Certificate of Analysis.

Facilities

We work with state-of-the-art equipment and chemistries for standard and modified backbone DNA and RNA synthesis. We use precise analytical characterization methods for oligos and oligo conjugates.

Typical QC includes purity analyses (HPLC), quantity (UV spectroscopy), and identity (Mass Spectroscopy). Other analytical options available include (structure/synthesis dependent or customer specified analysis) orthogonal HPLC, CE, PAGE, and multiwavelength UV-Vis analysis.

Dedicated Partnerships

Our experienced team will work with you to integrate a range of reagent categories with your product design control or commercialization plan, as applicable. We recognize the urgency of reagent production in supporting IVD and CLIA LDT development and product realization.

We can integrate into your program during any stage of the diagnostic project development cycle, while ensuring that manufacturing controls are in place for materials used during clinical trials. We are well-equipped for technology transfer, even if your reagents were previously obtained from other manufacturers.