Nucleic Acid Therapies Testing Services

Oligonucleotides (including RNAi pathways, Antisense Oligonucleotides, CRISPR technologies, and mRNA) each have their own unique analytical challenges. Eurofins BioPharma Product Testing's network of laboratories have supported both RNAi and mRNA development candidates from leading innovators and can support their unique testing requirements.

Oligonucleotide

Oligonucleotides are produced through a synthetic solid-phase chemical synthesis in a manner that likens them directly to traditional small molecule pharmaceuticals. However, on a cellular level they display a mode of action which is typical of a biological product. This lack of ready definition, as either a large or small molecule, has led to many challenges from a regulatory perspective. Neither the FDA nor EMA have issued official documentation with respect to expectations surrounding quality control of oligonucleotides. Eurofins BioPharma Product Testing groups analytical testing by small oligonucleotides (Anti-Sense, siRNAs, and Aptamers) and mRNA products (vaccines and cell therapies). Whereas some of the more general safety and compendial testing does overlap, each molecule has a vast array of advanced analytics to properly control structural, physiochemical composition, as well as purity and impurities of the test material.

Oligonucleotides produced by solid-phase organic synthesis include antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), and aptamers, with the former two moieties accounting for over 80% of the approved market. Analytical assays available include:

Purity/Impurity of Starting Materials by High Resolution Mass Spectrometry (HRMS)
Purity/Impurity by Ion Exchange, RP-HPLC and CE
Fourier transform infrared spectroscopy (FTIR)
Residual Solvents and Metals by GC and ICP/MS
Identity by Reverse Transcription (RT) Sanger Sequencing
Total RNA by Spectroscopy

Oligonucleotide formulations often include liquid nanoparticle technology with polyethylene glycol (PEG) adding to the analytical complexity. We have developed the following analytical methodology to characterize the lipid and drug product:

% RNA encapsulation by Ribogreen
Lipids by HPLC-CAD
Particle Size and Dispersity by Light Scattering

Eurofins BioPharma Product Testing offers comprehensive cGMP testing supporting drug substance/drug product programs, ranging from raw materials release testing through sterile fill/finish services for Oligonucleotides, including:

Please contact us to discuss your specific requirements, access our broad capabilities, and deep experience.

Our experienced project management and technical teams serve as your single-source solution for all of your testing needs and our secure 24/7 online data portal, LabAccess.com, provides timely access to your test results.

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