Oligonucleotides Testing Services

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

• Characterization of Exons (5’ Cap) and Poly (A) Tails (3’End) by Orthoginal Mass Spec
• Purity/Impurity of Starting Materials by LC/MS
• Purity/Impurity by Ion Exchange RP-HPLC and CE
• 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:

• Raw Materials
• Sterility
• Endotoxin
• Bioburden
• Particulate Matter
• Characterization
• Cell Based Bioassay/Potency
• Process Residuals/Residual Solvents
• Formulation
• Stability Storage & Testing
• Sterile Fill/Finish

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.