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Rezon Bio Launches as European CDMO for Biologics

Offers clients an end-to-end path from cell line development through GMP manufacturing and commercial supply.

Rezon Bio has launched as a European contract development and manufacturing organization (CDMO) for biologics, building on a legacy of advancing biologics from gene to global commercialization through established partners.

With two facilities in Gdańsk and Warsaw-Duchnice, Rezon Bio offers clients an end-to-end path from cell line development through GMP manufacturing and commercial supply. Both sites feature mirrored capabilities, enabling seamless technology transfer and flexible scale-up. The infrastructure is based on single-use systems for faster product turnover and accelerated delivery. Development platforms, including AMBR systems, are optimized to shorten early development cycles and de-risk scale-up.

“Rezon Bio is a new name, but it stands on a track record that already includes building a broad biosimilars portfolio – with two products launched worldwide through our partners,” said Adriana Kiędzierska-Mencfeld, the newly appointed CEO of Rezon Bio. “That experience is the foundation of our new CDMO offering. We know the challenges of developing and launching biologics because we have been through them ourselves. Now we are here to make that journey easier, faster and cost-efficient for our clients.”

Rezon Bio combines European location advantages with Poland’s strong biopharma talent base and cost structure. This allows the company to deliver competitive economics while maintaining quality. The company’s Gdańsk facility is EMA certified and US FDA approved, and its Warsaw-Duchnice site is EMA certified and planned for future US FDA licensing. Rezon Bio operates under global compliance frameworks.

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