Rapid. Reliable. Secure
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.
JavaScript is disabled. The Email button above will open your email client to contact info@biosyn.com.
Email: info@biosyn.com • Phone: +1 (972) 420‑8505
Trusted by biotech leaders worldwide for over 45 years of delivering high quality, fast and scalable synthetic biology solutions.