Rezon Bio has announced its launch as a European contract development and manufacturing organisation (CDMO) for biologics.
It enters the market as a new brand but builds on a proven legacy of advancing biologics from gene to global commercialisation 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 — that is, they have the same equipment and capabilities — which enables 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 optimised 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, 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 whilst 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 modelling, AI-enabled systems and project transparency tools help clients track milestones, anticipate risks and manage comparability – designed to reduce delays and accelerate 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 programmes while maximising customer value that benefits patients worldwide."
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.