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From Accelerated to Long-Term — Comprehensive Oligo Stability Testing.

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Oligonucleotide Stability Studies

ICH Q1A(R2)‑aligned programs for DNA/RNA, ASO, siRNA, and sgRNA — including accelerated, intermediate, and long‑term studies, stress testing, and sodium content trending with stability‑indicating methods.

ISO 9001: 2105 ISO 13485: 2016 ICH Q1 (R2) Methods GLP/cGMP Aligned
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Overview

We design and execute ICH Q1A(R2)‑aligned stability programs for DNA/RNA, ASO, siRNA, and sgRNA. Studies include accelerated, intermediate, and long‑term storage, with photostability and freeze‑thaw as needed—plus trending plots and a final stability summary.

Pull schedules and attributes are tailored to your formulation and intended use, with optional sodium content trending across pulls.

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At-a-Glance

  • Programs: 40 °C/75% RH (Accelerated), 30 °C/65% RH (Intermediate), 5–25 °C (Long‑term)
  • Pulls: Typical 0, 1, 3, 6, 12, 24 months (customizable)
  • Stability‑indicating: HPLC/CE/IEX + LC–MS identity
  • Residuals: GC (solvents), ICP‑MS (metals)
  • Sodium content: IC or flame photometry (trended)
  • Deliverables: Protocol, pulls, chromatograms/spectra, trending tables/plots, final report

Study Types

  • Accelerated: 40 °C / 75% RH
  • Intermediate: 30 °C / 65% RH
  • Long‑term: 5–25 °C as appropriate
  • Photostability (per ICH), Freeze‑thaw cycling
  • Stress studies: pH, heat, nuclease exposure

Pull Schedules & Sampling

  • Custom pull points (e.g., 0, 1, 2, 3, 6 months; extended as needed)
  • Aliquoting strategy to minimize freeze‑thaw events
  • Chain‑of‑custody, storage, and environmental monitoring included
  • Interim and final data packages with trending plots

Example Conditions & Pull Schedule

Condition 0M 1M 3M 6M 12M 24M Sodium Trending
Accelerated (40 °C/75% RH) ✓ ✓ ✓ ✓ — — Yes
Intermediate (30 °C/65% RH) ✓ ✓ ✓ ✓ ✓ — Optional
Long-term (5–25 °C) ✓ — ✓ ✓ ✓ ✓ Optional
Photostability ✓ — — — — — Optional
Freeze-thaw ✓ ✓ ✓ — — — Optional

✓ = typical pull point; schedules customizable per protocol. Sodium content may be trended by ion chromatography or flame photometry and reported at each pull.

✓ = typical pull point; schedules customizable per protocol. Additional pulls can be defined as needed. Sodium content can be trended and reported at each pull as requested.

Stability‑Indicating Methods

  • Identity: LC–MS (ESI) or MALDI–TOF; optional enzymatic digest mapping
  • Purity / Impurities: RP‑/IP‑RP‑HPLC, CE; IEX for charge variants; track shortmers, depurination, conjugate loss
  • Residuals: GC for solvents, ICP‑MS for elemental impurities
  • Sodium content: Ion chromatography or flame photometry — trended across pulls
  • General attributes: Karl Fischer water, pH, appearance; endotoxin/bioburden as required

Instrumentation & Options

  • HPLC/UPLC with UV and/or MS detection; CE; IEX
  • LC–MS / MALDI for intact mass; LC‑MS/MS for sequence mapping
  • GC with headspace for volatiles; ICP‑MS for metals
  • KF titration for moisture; pH and osmolality as needed
  • Optional sterility/microbial testing for aseptic programs

Sample Requirements

  • Typical minimum per condition/pull: ≥ 200 µg (method‑dependent)
  • Dry or buffered format; include sequence length, chemistry, purification, concentration
  • Shipping: ambient for DNA; cold chain recommended for RNA/ASO; insulated packaging

Data & Deliverables

  • Study protocol and finalized pull schedule
  • Chromatograms/spectra; impurity profiling; identity confirmation
  • Trending tables/plots for purity, impurities, sodium content, and general attributes
  • Interim summaries and a final stability report suitable for audits

Why Choose Bio‑Synthesis

  • Fit‑for‑purpose design — protocol tailored to sequence, chemistry, and intended use (RUO to GMP)
  • Broad modality support — DNA, RNA, ASO/siRNA/sgRNA; conjugates (GalNAc, lipid, PEG, dyes, biotin)
  • Regulatory alignment — ISO 9001/13485 QMS, GLP practices, audit‑ready data packages
  • Scientist‑to‑scientist support — from study design to final report
Release
Oligonucleotide Release
QC

Identity, purity/impurities, residuals, sodium content, and safety testing with signed CoA.

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Methods
Analytical Method Development & Validation

Scouting → optimization → transfer → ICH Q2(R2) validation with protocols, raw data, and reports.

See Method Validation
Manufacturing
Custom Oligonucleotide Synthesis

RUO to GMP‑aligned oligos; HPLC/PAGE, diafiltration; broad chemistry & conjugation support.

Explore Synthesis

Need a specific attribute trended?

We can add custom attributes (e.g., buffer ions, counter‑ions, conjugate ratio) to your study plan.

Customize My Study

Request a Study Plan

Share your formulation, storage conditions, and target shelf‑life — our team will design a fit‑for‑purpose protocol.


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FAQ

Which conditions do you support?
Accelerated (40 °C/75% RH), Intermediate (30 °C/65% RH), Long‑term (5–25 °C), plus photostability, freeze‑thaw, and stress studies.
Can you trend sodium content?
Yes. Sodium content can be trended by ion chromatography or flame photometry. We report values at each pull with limits you define.
What are typical deliverables?
Protocol, pull schedule, methods, chromatograms/spectra, impurity profiling, attribute trending tables/plots, and a final stability summary.
What sample amount is required?
Most studies run with ≥ 200 µg per condition/pull (method‑dependent). Complex panels or replicate runs may require more.

Contact

Email: info@biosyn.com • Phone: +1 (972) 420‑8505

Why Choose BioSynthesis

Trusted by biotech leaders worldwide for over 45 years of delivering high quality, fast and scalable synthetic biology solutions.

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