At Xoligo Biologics, we believe that data is as important as the molecules themselves. In nucleic acid therapeutics, every strand must be validated, every impurity measured, and every structure confirmed. That’s why our analytical and characterization services are designed to go beyond basic quality control—delivering the insights you need to move confidently from discovery to clinic.

Our platform integrates advanced analytical chemistry, molecular biology, and regulatory-ready documentation, ensuring that every dataset we generate stands up to investor scrutiny, regulatory review, and scientific rigor.

Identity & Structural Confirmation

Confidence begins with knowing exactly what you have.

• LC-MS/MS – Accurate mass determination for oligonucleotides, mRNA, and gRNAs.
• NMR & UV Spectroscopy – Structural confirmation for modified backbones and conjugates.
• Capillary Electrophoresis (CE) – High-resolution separation and size confirmation.
• Sequence Verification – Enzymatic digestion and sequencing-based validation.

Purity & Impurity Profiling

Impurities can compromise both safety and efficacy. We provide comprehensive profiling to eliminate uncertainty.

• HPLC (RP, IEX, SEC) – Separation of full-length product from truncated sequences and byproducts.
• PAGE – High-sensitivity gel analysis for short fragments and degradation products.
• Impurity Quantification – Residual solvents, salts, and protecting groups.
• Regulatory Documentation – Detailed impurity maps aligned with ICH and FDA guidelines.

Stability & Stress Testing

Understanding how your molecule behaves under different conditions is critical for program success.

• Accelerated Stability Studies – Heat, light, and pH stress testing.
• Long-Term Storage Testing – Shelf-life confirmation under GMP-compliant conditions.
• Formulation Compatibility – Data on oligo and RNA stability in buffers, excipients, and delivery vehicles.
• Degradation Pathway Analysis – Identification of breakdown products to support regulatory filings.

Functional Validation

Analytics must connect back to biology. We ensure that your molecules don’t just look good on paper—they perform.

• In Vitro Translation Assays – Functional testing for mRNA products.
• Gene Silencing Assays – Verification of siRNA and antisense activity.
• Cleavage Assays – Activity confirmation for CRISPR gRNAs and nucleases.
• Custom Biological Testing – Tailored assays aligned to your therapeutic application.

Data Packages & Regulatory Readiness

We don’t stop at testing—we deliver comprehensive, submission-ready documentation to accelerate your regulatory pathway.

• Batch Release Reports – Detailed analytics for preclinical and clinical use.
• CMC Data Support – Full integration with IND and CTA submissions.
• Comparability Studies – Data continuity across process changes or scale-up.
• Audit-Ready Systems – Documentation designed to withstand FDA and EMA scrutiny.

The Xoligo Standard

At Xoligo Biologics, analytics isn’t an afterthought—it’s built into everything we do. By combining advanced instrumentation with a culture of precision, we give clients the clarity they need to advance programs faster, reduce risk, and meet regulatory expectations with confidence.

When you partner with us, you don’t just get molecules—you get proof, backed by data that moves your science forward.