Rezon Bio achieved a 97% batch success since 2024. These results reflect the process robustness and quality discipline built through years of biologics development and commercialization experience, where batch failure carries direct commercial consequences. On the regulatory side, Rezon Bio’s team carries a track record of successful audits by FDA, EMA, MHRA, SFDA, ANVISA and other regulatory authorities, as well as experience navigating complex regulatory pathways including Phase 3 waivers. Both GMP manufacturing sites, Gdansk (clinical) and Warsaw-Duchnice (late-phase clinical and commercial, FDA approved February 2026), operate under a unified quality management system to ensure consistent standards across all programs.
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