Codexis Inc. has achieved ISO 9001:2015 certification for its Redwood City headquarters, covering the research and development facilities, the ECO Synthesis Innovation Laboratory, and the non‑GMP manufacturing plant. The certification confirms that the company has implemented a robust quality‑management system that meets international standards for consistency, traceability, and continuous improvement across all manufacturing and support functions.
The ISO 9001 certification is a critical enabler for Codexis’s siRNA therapeutics portfolio. By validating its quality processes, the company can more readily satisfy the stringent regulatory requirements of pharmaceutical partners and accelerate the commercialization of its enzymatic ECO Synthesis platform, which is designed to produce RNAi therapeutics at scale with lower cost and environmental impact.
President and CEO Alison Moore said the certification “demonstrates Codexis’s dedication to quality and customer service.” She added that the company is also preparing a 34,000‑square‑foot GMP facility in Hayward, California, and that the ISO 9001:2015 certification will support the transition to the upcoming ISO 9001:2026 standard slated for release in September 2026.
The certification strengthens Codexis’s position as a reliable partner for siRNA manufacturing, potentially easing regulatory approvals and attracting new customers who require proven quality controls. It also signals to investors that the company is investing in operational excellence and scalability, which could translate into long-term cost efficiencies and competitive advantage.
Overall, the ISO 9001:2015 certification marks a significant milestone in Codexis’s journey to become a leading provider of high‑quality, enzymatically produced RNA therapeutics.
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