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Nucleic Acid Bioanalytical Development & Testing

Life Sciences / CDMO/CRO Services / Nucleic Acids / Bioanalytical Services

Comprehensive Bioanalytical Services

Before you can proceed with dosing and administration activities, prepare to make informed decisions with reliable bioanalytical data detailing your prospective compound’s safety and efficacy. Our highly experienced team performs GLP- and GCLP-compliant bioanalytical method development, validation, and testing of samples from (non)human tissues. By conducting this bioanalysis, the resulting insights support drug metabolism and pharmacokinetics studies for diverse drug candidates, such as small molecules, oligonucleotides, mRNA/LNPs, and viruses/virus-like particles. We support a variety of analytical techniques to serve your needs.

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Supported Drug Products

We are experienced in a variety of drug products, which enables us to identify barriers more rapidly and provide insightful guidance for future development. Whether your needs entail method development, method validation, or complete bioanalytical lab services, our partnership drives forward development of your nucleic acid therapeutic.


Compared to small organic molecules, oligonucleotides’ heightened behavior and degradation characteristics present challenges to bioanalysis. Therapeutic oligonucleotides are strategically modified to resist nucleases in biological tissues and enhance stability for effective delivery. In turn, these compounds are generally too short for quantitation with traditional PCR-based techniques used for DNA and RNA molecules. We use LC-MS/MS to identify and quantitate metabolites formed in biological tissues. Our experts apply their diverse experience to the extraction of oligonucleotides from biological tissues and analysis by electrospray mass spectrometry.

Lipid Nanoparticles (LNPs)

Encapsulation into LNPs enhances the drug product formulation of mRNA and other nucleic acid-based therapeutics, which, without chemical modifications, rapidly degrade in vivo. To more effectively deliver nucleic acids, we support PCR-based (e.g., qPCR, RT-qPCR) methods for the quantitation of specific nucleic acid sequences in biological tissues and LC-MS/MS methods to quantitate the novel lipids in the LNP formulation.

Virus & Virus-like Particles (VLPs)

We support development and testing of protein-containing therapeutics with ELISA-based methods when appropriate antibodies are available. Alternatively, we develop PCR-based methods targeting a unique sequence in the viral particle or use LC-MS/MS based methods to quantitate the protein capsid.

Integrated Laboratory Services  

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project. 

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