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Scouting → optimization → transfer → ICH Q2(R2) validation for DNA/RNA oligonucleotides. Identity, purity/impurities, residuals, elemental impurities, and general attributes with audit‑ready documentation.
End‑to‑end oligo analytical method support—from scouting and optimization to client method transfer, verification, and full ICH Q2(R2) validation. We generate audit‑ready protocols, raw data, and summarized validation reports.
Assays span identity (LC–MS/MALDI), purity/impurities (HPLC/CE/IEX), residual solvents (GC), elemental impurities (ICP‑MS), and general attributes (KF, pH, optional sodium content).
Example matrix — finalized per assay and intended use. "KF / pH / Sodium" covers general attributes including Karl Fischer water, pH, and optional sodium content trending.
Identity, purity/impurities, residuals, sodium content, and safety testing with signed CoA.
Accelerated/intermediate/long‑term programs with stability‑indicating methods and sodium trending.
RUO to GMP‑aligned oligos; HPLC/PAGE, diafiltration; broad chemistry & conjugation support.
We can transfer and verify it, then design an ICH Q2(R2) validation plan around your intended use
Tell us about your assay and intended use — we’ll return a phased plan with timelines and documentation deliverables.
By submitting, you agree to be contacted regarding your request.
Identity, purity/impurities, residual solvents, elemental impurities, Karl Fischer water, pH/osmolality, and optional sodium content trending.
We finalize a protocol with acceptance criteria, then execute accuracy, precision, specificity, linearity/range, LoD/LoQ, robustness, and system‑suitability runs as required by ICH Q2(R2).
Yes. We perform transfer with verification, instrument suitability checks, and documentation, then proceed to validation if requested.
Development typically needs ≥ 300–500 µg per iteration; validation requires additional aliquots for accuracy/precision/robustness runs.
Email: info@biosyn.com • Phone: +1 (972) 420‑8505
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