Manufacturing Facilities – Oligos for IVD, Molecular Dx, & Therapeutics
Our commitment to quality and reliability is supported by our ongoing efforts to maintain control of critical components in oligo production. We are
dedicated to producing reagents in-house and maintaining production in our headquarter’s manufacturing facility. This eliminates contamination
opportunities and our longstanding experience leads the way in ensuring the highest quality and consistency.
We strive for complete transparency in our process. Our system of quality and dedication to purity creates the optimal platform for oligo manufacturing success.
Raw Material Handling
Pending release to specification, raw materials such as oligonucleotide synthesis reagents, chemicals, and solvents
are quarantined in dedicated areas, using appropriate storage equipment as needed. Following documented release, these are moved to controlled released inventory.
Reagents that require formulation for use in synthesis and purification are formulated per batch record in suitable
environmental conditions within specified limited-access area(s). This maintains reagent quality and purity (e.g. dry
atmosphere for amidites; etc.) as specified in the formulation record.
Machine-synthesis of oligonucleotides is carried out in the dedicated oligo synthesis suite within cartridges
known as columns. Columns contain porous glass particles of solid-support, on which the oligo is assembled via
sequential passage of chemical solutions through each column. Each column is a closed system, protected from
lab environmental- and cross-contamination during synthesis. As a result, machine synthesis of different oligo
sequences may be carried out in parallel within these sealed columns, using computer controlled reagent delivery.
Post-machine-synthesis handling requires special segregation measures to be taken for each oligo. After chemical
synthesis, the oligo is cleaved from the solid support cartridge and, as a liquid solution, is now increasingly
susceptible to cross-contamination if mishandled. TriLink has carried out risk analyses to identify potential sources
of contamination throughout processing, and mitigates these by implementing suitable procedures and/or facility
and equipment controls for each step. Therefore, specialized dedicated areas, equipment, and handling are
assigned to the latter steps of oligo cleavage. Other key and controlled steps are desalting, deprotection, solidsupport,
sample concentration (drying), post-machine synthesis steps or conjugation chemistry, and purification.
Material flow and personnel flow between these areas is carefully controlled.
At TriLink, we understand that purification of oligos offers considerable potential for contamination, as multiple
fractions are typically collected during the chromatographic purification. These fractions are then analyzed as an
in-process procedure in order to identify the optimal ones to include in the purified pool. Through our thorough
understanding of the potential for contamination, we maintain the utmost in care in material handling. In addition
to limited access, gowning, and operating in a HEPA filtered lab, the fraction collection is maintained under positive
pressure airflow to eliminate external contamination from entering collection tubes during this part of the process.
Process control and Quality Control are carried out during every phase of oligo synthesis. As noted above, samples
may be taken for analysis of content or quality. Our Quality Control lab uses validated equipment maintained under
our Validation Master Plan for all testing of materials.