Rezon Bio launches as a European biologics CDMO combining cost efficiency and digital innovation.

September 29, 2025 – BioManufacturing, Logistics, Manufacturing and Packing, Other, PharmaceuticalCDMO, GMP manufacturing, Rezon Bio, biologics, biopharmaceutical, cell line development

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

29 September 2025 — Gdańsk, Poland — 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 Duchnice-Warsaw, 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. Rezon Bio operates under global compliance frameworks to meet the highest regulatory standards. Our Gdańsk facility is EMA certified and US FDA approved. Our Warsaw-Duchnice site is EMA certified and planned for future US FDA licensing.

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 maximising 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 science-driven contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of mammalian biologics. Headquartered in Poland, Rezon Bio offers integrated solutions spanning cell line development, commercial drug substance manufacturing, and drug product development. The company operates with state-of-the-art facilities, world-class teams, and a proven track record of regulatory and commercial success. Drawing on a legacy of biosimilars development and global commercialization, Rezon Bio combines experience, digital transparency, and cost-to-value efficiency to help clients move from concept to market with confidence. Visit: rezonbio.com.

Trzy Lipy 3, Building A 80-172 Gdansk, Poland