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Oligonucleotides

DNA Oligos
RNA Oligos
Modified Oligos
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Oligos for IVD & Molecular Dx
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Oligos for IVD & Molecular Dx

Fulfilling Broad Customer Needs

TriLink diagnostic oligo products include robust DNA and RNA modification options, providing our customers with a variety of specialized conjugates and unique probe labels that are also offered in our research oligo products. We understand that diagnostic medical device technologies require diverse oligo modifications at different scales of synthesis. Our expertise and extensive selection of modifications and conjugates ensure that we can meet your molecular diagnostic oligonucleotide synthesis requirements. We can do this at all stages of your product development project, at the scale and purity to fit your commercial needs. Our extensive OEM program 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. During diagnostic product development and technology transfer, we provide oligos to support the following phases:


Research Oligo

Our research oligos are synthesized using the same chemistry and reagents as our diagnostic oligos (below). The cost and turnaround time are reduced due to a smaller synthesis scale, production efficiencies of standardized protocols, significant parallel processing, and standardized QC for oligo types (unlabeled, modifications, etc.). Although a process control, raw material control, and traceability is in place for research oligos, a batch record is not provided.

Pilot Oligo

Pilot oligo lots provide an important step towards commercialization. These are produced in the cGMP lab suites under a drafted fully traceable batch record that we prepare based on our experience and information on the specific research oligo, when available. We work with the diagnostic product developer to establish oligo analytical chemistry specifications that ensure robust molecular diagnostic assay functional performance is achieved with pilot and ultimately, diagnostic oligos.

Diagnostic Oligo

Synthesis of this category of oligo can be used for in vitro diagnostics (IVD), laboratory developed tests (LDT) under CLIA, and analyte specific reagents (ASR). Diagnostic oligos are used for clinical trial performance validation and post-launch diagnostic test manufacturing. A master batch record is used to prepare each oligo with full material and process traceability within our cGMP system. Once the batch record is reviewed and approved, a Certificate of Conformance is generated and provided with each oligo. Typically, a Quality Agreement and a Supply Agreement are established between clients and Trilink at this stage of oligo production.


Quality

We operate our cGMP facility under an ISO9001 certified Quality Management System, and are fully compliant with cGMP under QSR 21CFR part 820, 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. Read more about our manufacturing facilities here.

Dedicated Partnerships

Our experienced team will work with you to integrate a range of oligo categories with your product design control or commercialization plan, as applicable. We recognize the urgency of diagnostic oligo 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 oligo manufacturing controls are in place for materials used during clinical trials. We are well-equipped for oligo technology transfer, even if your research oligos were previously obtained from other manufacturers.

Oligonucleotides for Research

"When is my oligo pure enough”


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