Stability study design, analytical testing and reporting support for oligonucleotide development programs.
ICH Q1A(R2)-aligned stability programs for DNA, RNA, ASO, siRNA and sgRNA can include accelerated, intermediate and long-term studies, stress testing, photostability, freeze-thaw and sodium content trending.
Bio-Synthesis designs and executes oligonucleotide stability studies for DNA/RNA, ASO, siRNA and sgRNA programs. Studies can include accelerated, intermediate and long-term storage, with photostability, freeze-thaw and stress conditions added when needed.
Pull schedules and testing attributes are tailored to formulation, storage conditions, intended use and target shelf life. Stability-indicating methods can track purity, impurities, identity, residuals, sodium content and general attributes across each pull.
Study design can be configured for RUO, GLP, diagnostic, ISO13485 or cGMP-oriented workflows depending on documentation requirements and program stage.
A compact view of the major stability study components Bio-Synthesis can configure for oligonucleotide lots.
Accelerated, intermediate, long-term, photostability, freeze-thaw and stress studies.
HPLC, CE, IEX, LC-MS identity, residuals, elemental impurities and general attributes.
Protocols, chromatograms, spectra, trend tables, plots, interim summaries and final reports.
A practical view of study timelines, methods and deliverables.
Core Stability
Typical programs include 40 °C / 75% RH accelerated, 30 °C / 65% RH intermediate and 5-25 °C long-term storage conditions, adjusted to the formulation and intended use.
Handling Stress
Freeze-thaw cycling, temperature excursions and shipping-condition studies help assess handling robustness for liquid, lyophilized or buffered oligo formats.
Forced Stress
Stress studies can help identify degradation pathways and support stability-indicating method development for sensitive RNA, ASO, siRNA or conjugated oligos.
Note: ✓ = typical pull point. Additional pulls can be defined as needed. Sodium content can be trended by ion chromatography or flame photometry and reported at selected pulls.
Stability-indicating methods track degradation, impurity growth, identity, moisture, residuals and formulation-related attributes over time.
The study plan should define sample amount, storage format, pull points, testing attributes and chain-of-custody before study start.
Sample Requirements
Study Setup
Deliverables can be scaled from focused interim data tables to complete stability-summary packages for audit-ready workflows.
Identity, purity, impurity, residual, sodium and safety testing with CoA documentation.
Explore Release QC →
Scouting, optimization, transfer and ICH Q2(R2)-aligned validation.
See Method Validation →
RUO to cGMP-aligned oligos with purification, diafiltration and conjugation support.
Explore Synthesis →
Connect stability studies with release QC, analytical method development, process development and oligo synthesis.
Include modality, sequence or length, chemistry, formulation, storage condition, target shelf life, pull schedule and required test attributes.
Trusted by biotech leaders worldwide for over 45+ years of delivering high quality, fast and scalable synthetic biology solutions.