Innovate with Confidence: Oligonucleotide Analysis
Unlock the potential of genetic therapeutics with our cutting-edge Oligonucleotide Testing services. Whether it’s DNA, RNA, mRNA, siRNA, ASO, CRISPR, or RNA editing-based drugs, we’re your trusted partner for precision analysis. Our state-of-the-art facilities and expert team guarantee accurate assessment, sequence validation, purity checks, and functional assays.
We’re dedicated to accelerating your research and drug development process, offering fast turnaround times and competitive pricing.
Join leading biotech and pharmaceutical companies in harnessing the power of oligonucleotides with our trusted testing services. Elevate your science and innovation - partner with us today!
Background
Information-based therapeutics, including oligonucleotides, mRNA vaccines, and base editing tools, demand meticulous focus on their precise sequences, distinct chemical compositions, and optimized delivery mechanisms to ensure their effectiveness as potent medications.
Compliance Compass
At present, regulatory frameworks for these innovative medicines are still evolving. Collaborate with us to gain access to expert guidance, ensure regulatory compliance, utilize state-of-the-art GMP testing facilities, and leverage our extensive experience in navigating this dynamic landscape.
Why Choose Eurofins BioPharma Product Testing?
- Our industry leading online data portal, LabAccess.com, provides customers access to our LIMS system, allowing 24-hour access to data.
- Our teams have 10+ years’ experience in developing assays to support Oligo and mRNA programs from early phase through commercialization.
- Our labs have established more than 60 assays, including compendial and platform methods, in support of several dozen Oligonucleotide and mRNA products across all phases of development and commercialization.
- Our scientists are contributing members of BioPhorum as well as USP, enabling them to collaborate with industry and regulatory professionals to remain up-to-date with the latest testing capabilities.
Testing Services
- Appearance: Visual Inspection, Osmolality, pH
- Identity and Concentration: IP-RP-HPLC, IEX, ESI-MS, HRMS
- Sequence: HRMS, Sanger Sequencing
- Size, Integrity, Aggregation and Fragmentation: FA/CE, IP-RP-HPLC
- Purity and Impurity Profile: IP-RP-HPLC, IEX, ESI-MS, HRMS
- 5’ Capping Efficiency: LCMS
- Poly(A) Tail Length: LCMS
- dsRNA: Immunodetection
- Potency: Cell Free Translation or Cell-based translation with Flow Cytometry, ELISA, Gel Electrophoresis or Western Blot endpoint
- Residual Protein, Residual HCP: ELISA, Fluorometry
- Residual DNA: qPCR, ddPCR
- Residual Solvents: GC
- Heavy Metals/Counterions: ICP-MS
- Particle Analysis: DLS, AUC
- Safety: Particulate Matter, Sterility, Bioburden, Bacterial Endotoxins
- Container Closure Integrity Testing (CCIT)
Oligonucleotide and mRNA formulations often include lipid 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:
- Particle size and morphology by light scattering
- Lipid ID and Content: HPLC-CAD
- RNA content and Encapsulation Efficiency: Fluorometry (RiboGreen)
- Polydispersity: DLS, CryoTEM
- Particle Morphology by Cryo-TEM
- Heavy Metals/Counterions: ICP-MS
- Particle Structure by NMR
