Codexis Achieves Stereochemical Control in siRNA Synthesis via ECO Synthesis Platform at TIDES USA 2026

Stereochemical control in siRNA manufacturing has moved from theoretical priority to demonstrated capability: Codexis presented first-of-kind data at TIDES USA 2026 showing full-length siRNA synthesis with precise phosphorothioate stereochemistry management using its ECO Synthesis® Manufacturing Platform, a development with direct implications for process validation strategies at contract manufacturers scaling toward large-population indications.

The three-dimensional arrangement of atoms within an oligonucleotide molecule influences both efficacy and product quality, parameters that QA directors and regulatory leads will recognise as critical quality attributes under ICH Q10-aligned quality systems. A panel at the conference, drawing representatives from Corsera Health, Arrowhead Pharmaceuticals, and Wave Life Sciences, framed stereochemical control as an increasingly necessary factor for optimising potency and enabling higher-concentration dosage forms, not merely a refinement.

Codexis also disclosed that ECO Synthesis can now initiate enzymatic RNA synthesis from a single nucleotide, removing the requirement for a chemically-synthesised starter oligonucleotide. For manufacturers using fragment ligation strategies, an approach gaining traction across the siRNA supply chain, fully enzymatic fragment production, combined with Codexis-engineered ligases, represents a materially different upstream process architecture. Eliminating the starter oligonucleotide step reduces input complexity and strengthens the case for end-to-end enzymatic workflows under 21 CFR Part 211 process control expectations.

Sustainability metrics accompanied the technical disclosures. Codexis reported the ECO Synthesis platform achieved more than a 50% reduction in global warming potential versus conventional synthetic approaches, with approximately 2.7-fold lower global warming potential on an input materials basis. Reduced organic solvent use and aqueous processing were cited as primary drivers, factors that also carry weight in environmental impact assessments increasingly required by regulatory agencies during facility inspections and new product filings.

For plant heads evaluating capacity expansion for RNA therapeutics, the convergence of stereochemical control, starter-oligonucleotide elimination, and reduced solvent burden in a single platform narrows the gap between laboratory-scale enzymatic synthesis and commercially viable GMP manufacturing.

The next measurable checkpoint will be whether Codexis translates the TIDES data into validated process packages that contract manufacturers can qualify within existing GMP frameworks.

Source: Codexis, Inc. via GlobeNewswire, 20 May 2026.