Analytical & Stability Services
Comprehensive analytical characterization and stability evaluation are essential for ensuring the quality, consistency, and development readiness of oligonucleotide therapeutics. Due to their complex chemical structures, sequence variations, modifications, and formulation characteristics, oligonucleotide products require specialized analytical strategies throughout the development lifecycle. Protheragen provides integrated oligonucleotide analytical and stability services to support drug substance and drug product development, including analytical method development, structural characterization, impurity profiling, quality evaluation, and stability studies.
Overview of Analytical & Stability Services
Analytical characterization and stability assessment play a critical role in the development and manufacturing of oligonucleotide therapeutics. Unlike conventional small molecules, oligonucleotides possess complex molecular structures, diverse chemical modifications, and sequence-dependent characteristics that require advanced analytical approaches to confirm identity, purity, integrity, and product quality.
A comprehensive analytical strategy typically includes structural characterization, impurity analysis, assay determination, physicochemical evaluation, and stability monitoring. These analytical studies support the understanding of critical quality attributes (CQAs), guide process optimization, and ensure consistency between development batches and future manufacturing stages.
Stability studies provide essential information regarding product degradation pathways, storage conditions, shelf-life potential, and formulation performance. By integrating analytical testing with stability evaluation, developers can identify potential risks and establish appropriate control strategies during CMC development.
Fig.1 Two LC-MS approaches for analytical characterization of oligonucleotides in different stages of early drug discovery. (Stavenhagen K, et al., 2025)
Our Services
Comprehensive analytical characterization and stability evaluation are essential for understanding oligonucleotide product quality, supporting process optimization, and ensuring development readiness. Due to their complex molecular structures, sequence-specific characteristics, and diverse chemical modifications, oligonucleotide therapeutics require specialized analytical strategies throughout the development and manufacturing lifecycle.
Protheragen provides integrated oligonucleotide analytical and stability services supporting starting materials, process intermediates, drug substances, and drug products. Our capabilities combine advanced analytical approaches with systematic stability evaluation to help identify critical quality attributes, monitor product consistency, and support CMC development from early research through clinical-stage programs.
Analytical Services
Oligonucleotide therapeutics require comprehensive analytical characterization due to their complex structures, chemical modifications, and potential impurity profiles. Reliable analytical methods are essential for confirming product identity, evaluating purity, monitoring quality attributes, and supporting manufacturing development.
Protheragen provides specialized oligonucleotide analytical services covering drug substance and drug product characterization, impurity analysis, method development, and quality evaluation to support different stages of therapeutic development.
Stability Study
Stability studies are essential for understanding the shelf-life, storage conditions, and degradation characteristics of oligonucleotide drug substances and drug products. Due to sensitivity to hydrolysis, oxidation, temperature variation, and formulation conditions, systematic stability evaluation is critical throughout the development process.
Protheragen provides comprehensive oligonucleotide stability study services to assess product performance under various storage and stress conditions, supporting formulation optimization, CMC development, and clinical manufacturing readiness.
Applications of Oligonucleotide Analytical & Stability Services
Oligonucleotide therapeutics encompass diverse molecular formats with different structural characteristics, chemical modifications, and quality requirements. Protheragen provides customized analytical characterization and stability evaluation strategies for various oligonucleotide products throughout the development lifecycle.
- Antisense Oligonucleotides (ASOs)
ASOs require comprehensive analytical evaluation to confirm sequence integrity, chemical modifications, purity, and degradation profiles. Analytical characterization supports process optimization and quality assessment during development.
Analytical Applications:
- Sequence confirmation
- Purity and impurity profiling
- Chemical modification analysis
- Stability assessment
- Small Interfering RNAs (siRNAs)
siRNA products often involve duplex structures, chemical modifications, and delivery technologies requiring specialized analytical approaches to evaluate molecular integrity and formulation performance.
Analytical Applications:
- Duplex integrity evaluation
- Strand analysis
- Encapsulation or formulation assessment
- Stability monitoring
- Phosphorodiamidate Morpholino Oligomers (PMOs)
PMOs possess unique backbone chemistry requiring tailored analytical strategies to evaluate molecular characteristics and manufacturing consistency.
Analytical Applications:
- Molecular characterization
- Purity evaluation
- Process-related impurity analysis
- Stability studies
CpG oligonucleotides used for immune modulation require reliable analytical control to ensure product consistency and quality.
Analytical Applications:
- Sequence identity confirmation
- Purity determination
- Degradation analysis
- Stability evaluation
- LNP-based RNA Formulations
Lipid nanoparticle-based products require integrated analytical approaches to evaluate both nucleic acid components and delivery system characteristics.
Analytical Applications:
- Particle size analysis
- Encapsulation efficiency
- RNA integrity assessment
- Formulation stability evaluation
Key Analytical Technologies
Protheragen applies advanced analytical technologies to characterize oligonucleotide products and support quality evaluation throughout development.
HPLC / UPLC Analysis
Purity assessment and impurity profiling of oligonucleotide products.
LC-MS Characterization
Accurate molecular weight determination and structural confirmation.
Capillary Electrophoresis
High-resolution analysis of oligonucleotide integrity and purity.
UV Spectroscopy
Quantitative analysis and concentration determination.
Stability-Indicating Methods
Monitoring degradation pathways during stability studies.
Analytical Testing Scope
Protheragen provides customized manufacturing strategies according to project requirements, supporting:
| Sample Category |
Sample Category |
Sample Category |
| Starting Materials |
Quality evaluation of raw materials and synthesis-related components to ensure consistency and suitability for oligonucleotide production. |
- Identity confirmation
- Purity assessment
- Impurity evaluation
- Quality attribute characterization
|
| Synthesis Intermediates |
Analytical monitoring of intermediate products generated during oligonucleotide synthesis and purification processes. |
- Reaction monitoring
- Intermediate purity analysis
- Process-related impurity assessment
- Synthesis efficiency evaluation
|
| In-process Samples |
Analytical testing to monitor critical process steps and support process optimization during development and manufacturing. |
- Process monitoring
- Impurity profile evaluation
- Critical process parameter assessment
- Batch-to-batch consistency evaluation
|
| Oligonucleotide Drug Substance (API) |
Comprehensive characterization of purified oligonucleotide active pharmaceutical ingredients to confirm product quality and molecular integrity. |
- Identity and sequence confirmation
- Molecular weight determination
- Purity and impurity profiling
- Structural characterization
- Degradation analysis
|
| Oligonucleotide Drug Product |
Analytical evaluation of formulated oligonucleotide products, including injectable, lyophilized, and advanced delivery formulations. |
- Appearance and physicochemical evaluation
- Concentration determination
- Product integrity assessment
- Formulation quality evaluation
- Stability-indicating analysis
|
| Stability Samples |
Analytical monitoring of samples collected during stability studies to evaluate product performance and shelf-life. |
- Purity changes
- Degradation profile monitoring
- Product integrity assessment
- Storage condition evaluation
|
Why Choose Protheragen
- Integrated Analytical Platform
Protheragen provides comprehensive analytical support across oligonucleotide development stages, from early characterization to clinical manufacturing support.
- Modality-Specific Expertise
Our analytical strategies are tailored for diverse oligonucleotide formats, including ASOs, siRNAs, PMOs, CpG, and RNA-based therapeutics.
- Comprehensive Quality Evaluation
Advanced analytical approaches enable detailed assessment of identity, purity, structural characteristics, and stability profiles.
- Development-Focused Support
Analytical data generated by our platform supports process optimization, formulation development, and CMC decision-making.
Customized analytical and stability programs can be designed according to product stage, development objectives, and regulatory requirements.
High-quality analytical data is essential for understanding oligonucleotide products and making informed development decisions. Protheragen integrates analytical characterization, impurity evaluation, and stability assessment to support the advancement of oligonucleotide therapeutics from early development to clinical manufacturing. Through comprehensive analytical solutions and scientific expertise, we help partners establish robust quality strategies and accelerate the development of next-generation nucleic acid medicines. Contact us to discuss your oligonucleotide analytical requirements and develop a tailored testing strategy for your drug substance and drug product programs.
Reference
- Stavenhagen K, et al. "Rapid and flexible analytical characterization of oligonucleotides in early drug discovery" Journal of Chromatography A. 2025; 1765.
