Wed Feb 04, 2026

Integrated Oligonucleotide Bioanalysis and Development Support

Oligonucleotide-based therapeutics are rapidly reshaping modern medicine, offering targeted solutions for diseases driven by genetic and molecular dysfunction. As antisense oligonucleotides, siRNA, and related modalities continue to advance through development pipelines, their complexity demands highly specialized analytical strategies.

United Pharmaceuticals delivers end-to-end bioanalytical and scientific support for oligonucleotide programs, enabling accurate characterization, quantification, and interpretation of data across preclinical and clinical stages. Our expertise spans complex biological matrices and challenging tissue types, ensuring reliable results that support informed development decisions.

 

Scientific Support from Early Research Through Clinical Development

Our bioanalytical scientists design and execute fit-for-purpose assays that address the unique challenges associated with oligonucleotide therapeutics. From early discovery through late-stage clinical trials, we develop sensitive and selective methods that minimize matrix interference and ensure robust quantitation across diverse study designs.

In addition to core bioanalysis, we provide complementary scientific services commonly required for oligonucleotide programs, creating a cohesive development framework that supports both efficacy and safety evaluation.

 

Specialized Capabilities Supporting Oligonucleotide Programs

Immunogenicity and Anti-Drug Antibody Assessment

We develop and validate immunogenicity and anti-drug antibody assays to evaluate potential immune responses associated with oligonucleotide therapies. These studies support regulatory expectations and help assess clinical risk related to safety and treatment efficacy.

 

PCR-Based Analytical Solutions

Our laboratories support a range of PCR methodologies, including quantitative real-time PCR and digital PCR, enabling highly sensitive and specific detection of oligonucleotide sequences. These approaches are particularly valuable for biodistribution, persistence, and mechanistic investigations.

 

Tissue-Focused Bioanalysis

United Pharmaceuticals has extensive experience performing tissue-based oligonucleotide analysis, including challenging matrices such as ocular, hepatic, and central nervous system tissues. These capabilities support target engagement, biodistribution, and translational assessments.

 

Regulatory and Development Guidance

Our experts provide strategic guidance throughout the development lifecycle, helping sponsors navigate regulatory expectations for oligonucleotide and advanced therapeutic programs. We align analytical strategies with evolving global guidelines to support successful submissions and inspections.

 

Experience That Drives Confidence

Our oligonucleotide bioanalysis team brings decades of hands-on scientific experience supporting complex development programs, with a proven track record across multiple therapeutic areas and study phases. This depth of expertise allows us to anticipate challenges early and design solutions that reduce development risk.

 

Advanced Bioanalytical Technologies for Oligonucleotide Quantification

United Pharmaceuticals employs a diverse suite of validated platforms and methodologies to support oligonucleotide analysis, including:

  • Multiplex biomarker and oligonucleotide detection using electrochemiluminescence-based platforms
  • Mass spectrometry–driven quantification of linear and conjugated oligonucleotides, including antisense oligonucleotides, siRNA, and aptamers
  • Solid-phase extraction and automated hybridization LC-MS/MS workflows for high specificity and sensitivity
  • In vitro plasma stability assessments, metabolite profiling, and plasma protein binding studies using advanced mass spectrometry systems

Our scientists provide technology selection recommendations based on sensitivity requirements, matrix complexity, dynamic range, throughput needs, and overall program objectives.

 

A Strategic Partner for Complex Modalities

United Pharmaceuticals combines scientific rigor, regulatory awareness, and technical depth to support oligonucleotide discovery and development programs with confidence. By integrating advanced analytics with thoughtful study design, we help sponsors generate high-quality data that translates across development stages.

Whether supporting early feasibility studies or regulated clinical trials, our oligonucleotide services are designed to accelerate timelines, strengthen data quality, and support informed decision-making.