- Polpharma Biologics has demerged its operations into two independent entities, with the establishment of Rezon Bio as a dedicated contract development and manufacturing organisation for biologics.
The Swiss-based parent company will retain the Polpharma Biologics brand and continue its biosimilars business. Meanwhile, Rezon Bio will operate CDMO services from two facilities in Poland – located in Gdańsk and Duchnice near Warsaw.
Proven Infrastructure and Regulatory Standing
Rezon Bio enters the market with established credentials. Both Polish sites feature mirrored capabilities. The company’s Gdańsk facility is EMA certified and US FDA approved. Our Warsaw-Duchnice site is EMA certified and planned for future US FDA licensing. The company reports a 98% batch success rate and has already supported the global launch of two biosimilar products through partner companies.
The facilities utilise single-use manufacturing systems designed to accelerate product turnover. Development platforms, including AMBR systems, aim to compress early-stage development timelines and reduce scale-up risks.
Competitive Positioning
Newly appointed chief executive Adriana Kiędzierska-Mencfeld emphasised the company’s practical experience in biologics development. “We know the challenges of developing and launching biologics because we have been through them ourselves,” she stated.
Chairman Konstantin Matentzoglu outlined the company’s market strategy: “We will disrupt the European CDMO landscape by being the most cost competitive and reliable partner.”
The company’s value proposition centres on Poland’s biopharma talent base and cost structure, combined with European regulatory proximity. Rezon Bio has integrated digital tools including process modelling, AI-enabled systems and project transparency platforms to support programme management and comparability assessments.
Service Scope
Rezon Bio offers end-to-end capabilities spanning cell line development through to commercial drug substance manufacturing. Drug product development is coordinated through qualified external partners. The mirrored-site configuration enables technology transfer and flexible capacity scaling.
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