Stability Studies for Oligonucleotide Drug Substance and Drug Product
Oligonucleotides are biopolymers sensitive to various environmental factors such as radiation, temperature, water, salt, oxidation, and pH. The stability of oligonucleotides is one of the key determinants for drug safety and efficacy. A prerequisite for stability studies is a stability-indicating analytical method.
Within our 7,000 ft² analytical laboratory space, we offer ICH-compliant stability studies for all stages of your program. These studies are performed for drug substance and drug product under non-GMP or GMP conditions, as applicable.
Our Stability Study Solutions:
- Stability studies for commercial oligonucleotide drug substance & product
- On-site sample storage according to ICH conditions
- Long-term GMP & non-GMP stability studies for oligonucleotide drug substance & product
- Customized & phase-appropriate stability study design
- In-use & solution stability studies
- Microbial & chemical hold-time studies
- Forced degradation & stress studies
- High-resolution LC-MS capabilities
FDA-inspected for the release of approved oligonucleotide drugs
High-Resolution LC-MS Capabilities
> 7,000 f² Analytical Laboratory Space
ICH-compliant Stability Studies
From Research to Market
Additional Analytical Services
- Reference standard characterization, including a variety of structural characterization tests
- Dose-formulation analysis
- Characterization of oligonucleotides in complex formulation
- Physicochemical characterization of oligonucleotides in solution, e.g. by DSC
- In vitro bioactivity assays
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