New brand with proven track record – EMA and FDA-audited mirrored-capability sites in Poland provide an accelerated path from development to commercialization.

Rezon Bio today announced its launch as a European contract development and manufacturing organization (CDMO) for biologics. It enters the market as a new brand, but builds on a proven legacy of advancing biologics from gene to global commercialization through established partners.

With two state-of-the-art 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 uncompromising quality. Both facilities have been audited by the EMA and FDA, and Rezon Bio operates under global compliance frameworks.

Digital innovation is central to the model. Process modeling, AI-enabled systems, and project transparency tools help clients track milestones, anticipate risks, and manage comparability – designed to reduce delays and compress time to market.

“We will disrupt the European CDMO landscape by being the most cost competitive and reliable partner,” said Konstantin Matentzoglu, Chairman of the Supervisory Board of Rezon Bio. “Our commitment is to accelerate programs while maximizing customer value that benefits patients worldwide. That is our Rezon.”

Rezon Bio’s first industry presence will be at the Festival of Biologics, European Biomanufacturing Summit, CPHI Frankfurt, and BIO-Europe, where its leadership and technical experts will be available for meetings: schedule a meeting with the Rezon Bio Business Development team.

About Rezon Bio

Rezon Bio is a biologics CDMO specializing in mammalian drug substance development and GMP manufacturing, with drug product coordinated via qualified external partners. Headquartered in Poland, the company operates two mirrored-capability facilities in Gdańsk and Warsaw-Duchnice audited by EMA and FDA. Drawing on a legacy of biosimilars development and global commercialization, Rezon Bio combines proven experience, digital transparency, and cost-to-value efficiency to help clients move from concept to market with confidence. Learn more at https://rezonbio.com or schedule a virtual introduction at https://rezonbio.dayschedule.com.

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