Oligonucleotides

ICON’s bioanalytical laboratories have built strong expertise across a broad range of analytical oligonucleotide methods, providing robust and reliable testing solutions to support the development of these advanced therapeutics throughout the different stages of clinical studies.

Oligonucleotide therapeutics represent a rapidly growing class of precision medicines, designed to modulate gene expression by targeting messenger RNA (mRNA) or, in some cases, DNA. These short strands of nucleic acids enable mechanisms such as gene silencing, splice correction, and mRNA degradation—unlocking therapeutic potential for previously 'undruggable' targets.

With increasing approvals and a robust pipeline across rare and common diseases, oligonucleotides are reshaping the landscape of modern drug development.

Therapeutic classes & structural complexity

Oligonucleotide drugs span a diverse range of modalities, each with unique structural and analytical challenges:

Antisense Oligonucleotides (ASOs)
Small Interfering RNAs (siRNAs)
MicroRNA Modulators
Aptamers
CRISPR-based Oligonucleotides

These molecules often undergo chemical modifications to enhance stability and efficacy, adding complexity to their bioanalytical evaluation.

Bioanalytical challenges in clinical trials

Oligonucleotide trials introduce novel analytical requirements that differ significantly from those for small molecules or proteins. Assays must be adapted to accurately quantify both parent compounds and metabolites using platforms such as:

LC-MS/MS
Ligand Binding Assays (LBA)
Polymerase Chain Reaction (PCR)

These methods must meet stringent regulatory expectations while accommodating the unique properties of oligonucleotide drugs.

Analytical platforms & methodologies

To support oligonucleotide development, a range of specialised platforms are employed:

Hybridisation Ligand Binding Assays
PCR-based methods
Ion Pairing (IP) LC-MS/MS, with or without Hybridisation Immunocapture (IC)

Each technique offers distinct advantages depending on the study’s objectives and molecular characteristics.

Why partner with ICON for Oligonucleotide Bioanalysis

Selecting the right analytical strategy is critical for successful clinical development. ICON’s bioanalytical laboratories provide customized assay development and validation for PK, PD, and immunogenicity assessments—ensuring robust, regulatory-compliant data from early-phase studies through submission.

By partnering with ICON you have access to:

Tailored method development

Customised Ligand Binding, LC-MS/MS, and PCR assays designed to meet study-specific requirements and regulatory standards.

Expert scientific & regulatory oversight

Guidance from seasoned experts ensures compliance and strategic alignment with evolving global regulations.

Reliable quality systems

Robust processes deliver consistent, reproducible results essential for successful drug development.

High-integrity data

Validated workflows and rigorous controls ensure accurate, traceable data for confident decision-making.

Global end-to-end Support

Comprehensive clinical trial services backed by advanced bioanalytical labs in the US and Europe, offering LC-MS/MS, LBA, qPCR, and flow cytometry capabilities.

Partner with ICON to advance your Oligonucleotide program

Leverage ICON’s scientific expertise, regulatory insight, and global infrastructure to accelerate your oligonucleotide drug development. Contact us today to explore tailored bioanalytical solutions that deliver high-quality data and drive confident decision-making from preclinical through clinical phases.

ICON’s bioanalytical laboratories have built strong expertise across a broad range of analytical oligonucleotide methods, providing robust and reliable testing solutions to support the development of these advanced therapeutics throughout the different stages of clinical studies.

Therapeutic classes & structural complexity