Oligonucleotide Characterisation Services
ZentriForce Pharma provides analytical services for oligonucleotide characterisation, supporting the development of antisense oligonucleotides, siRNA, mRNA and related modalities. Ensuring molecular weight, purity, structural integrity, and aggregation state is critical to product quality, batch consistency and regulatory acceptance. ZentriForce employs its available techniques — SV-AUC, AF4, DLS, SEC-MALS, and µ-DSC, to assemble a robust analytical profile for oligonucleotide APIs.
Oligonucleotide Characterisation – Analytical Outputs and Quality Attributes
- Determination of molecular weight distribution
- Size distribution and detection of aggregates or higher-order structures
- Purity assessment via advanced separation and light-scattering methods
- Evaluation of structural integrity and conformational properties
- Thermal stability assessment (via µ-DSC)
- Comparability analysis across batches, formulations, or process changes
Why Choose Oligonucleotide Services at ZentriForce Pharma?
- Hydrodynamic expertise: ZentriForce applies hydrodynamic techniques – SV-AUC and AF4-MALS – for size-based separation without stationary phase artifacts.
- Complementary methods: DLS and SEC-MALS provide cross-validation of size, polydispersity, and aggregation states.
- Thermal insights: µ-DSC offers data on melting transitions and thermal stability of the oligonucleotide or conjugates.
- Regulatory readiness: Analyses follow rigorous SOPs and quality systems; methods are suited for comparability and stability dossiers.
- Tailored workflows: Custom method development depending on modifications, conjugation, and formulation.
Techniques Employed in Oligonucleotide Characterisation
| Technique | Utility for Oligonucleotides |
|---|---|
| SV-AUC | Resolves species by size and density; useful for detecting aggregates, duplex vs single strands, or complexes in native solution |
| AF4 | Gentle separation of fragments, aggregates, or conjugated oligos in solution; avoids stationary-phase binding |
| DLS | Rapid hydrodynamic sizing and polydispersity screening in solution |
| SEC-MALS | Size-based separation coupled to absolute molar mass and aggregation state quantification |
| µ-DSC | Measures thermally induced transitions (melting, folding, duplex stability) under native-like conditions |
Quality Assurance and Data Integrity
ZentriForce Pharma operates under a WHO-aligned quality system with nearly 30 procedural SOPs governing instrumentation, method validation, data handling, and reporting. All services are audit-ready, providing traceable raw data, SOPs, and documented workflows.
Through its comprehensive suite of advanced characterisation techniques, the company ensures regulatory-compliant analysis. Its Total Quality Assurance approach is designed to uphold the highest standards of product quality, safety, and efficacy, helping clients meet and exceed industry and regulatory expectations for oligonucleotide therapeutics.
Partner with ZentriForce Pharma
By integrating SV-AUC, AF4, DLS, SEC-MALS, and µ-DSC, ZentriForce Pharma provides a holistic and accurate characterisation solution for oligonucleotide therapeutics. Their expertise ensures that data support development, comparability assessments, and regulatory submissions.
📩 Contact ZentriForce Pharma Research to explore how their oligonucleotide characterisation services can support your project. Please complete the Quick Contact Form or email info@zentriforce.com
