Rapid. Reliable. Secure
Fast, compliant release testing for DNA/RNA oligonucleotides—covering identity, purity, impurities, safety testing, and complete CoA for GMP and non‑GMP lots.
Our Oligonucleotide Release QC program provides fast, compliant testing for DNA/RNA oligos with audit‑ready documentation. Panels cover identity, purity/impurities, safety testing, and general attributes so lots can be released with confidence for RUO, GLP, or GMP use.
Choose a standard non‑GMP QC panel for speed, a full GMP release panel with QA oversight, or a custom package with client method transfer and ICH Q2(R2) validation.
Techniques vary by sequence length, chemistry (PS, PN, boranophosphate, methylphosphonate), and mods (2′‑OMe, 2′‑F, LNA/BNA, cEt, dyes, lipids, GalNAc, PEG).
Final specs set per program needs and regulatory strategy.
ICH Q1A(R2) accelerated/intermediate/long‑term with stability‑indicating methods and summary reports.
Scouting → optimization → transfer → ICH Q2(R2) validation with protocols, raw data, and reports.
RUO to GMP‑aligned oligos; HPLC/PAGE, diafiltration; broad chemistry & conjugation support.
Tell us about your oligo and required release specs. A scientist will respond with a tailored panel and timeline.
By submitting, you agree to be contacted regarding your request.
Identity (mass and, if needed, fragment mapping), purity with impurity profiling, safety testing (endotoxin/bioburden), general attributes (water, pH, appearance), and a signed CoA against predefined specifications.
We start from typical ranges for modality and use‑case, then finalize with you to reflect risk, formulation, and regulatory strategy.
Yes. GMP panels include QA oversight, instrument/equipment traceability, and data package suitable for audits.
Most panels can be run with ≥ 200 μg. Complex impurity/elemental panels may require more—ask us for study‑specific guidance.
Non‑GMP panels typically 3–7 business days; GMP panels 7–15 days depending on scope and queue.
Yes. We routinely execute method transfer and verification and can perform full ICH Q2(R2) validation where needed.
Email: info@biosyn.com • Phone: +1 (972) 420‑8505
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