GMP Biologics Manufacturing Facilities
From biologics development to commercial supply, our two GMP-certified sites ensure speed, scalability, and uncompromising quality, approved by FDA, EMA, and ANVISA.
Why our GMP biologics facilities matter
Rezon Bio’s purpose-built facilities are designed to take biologics from early development through commercial supply.
Our biologics manufacturing facilities in Poland feature GMP-certified manufacturing, quality control labs, and R&D capabilities across two sites, delivering speed, scalability, and uncompromising quality.
Each location embodies our commitment to operational excellence and regulatory compliance, demonstrated by successful FDA, EMA, and ANVISA audits and an industry-leading batch success rate.
GMP-certified manufacturing
R&D and QC Labs
Scalability from early to commercial supply
Experienced teams and compliance
Clinical Biologics Manufacturing Site
Technical development and clinical batch production up to 2000+L, approved by EMA, FDA, and ROW
Gdańsk, Poland
Based in Gdańsk Science and Technology Park, our 7,500 m² GMP biologics facility is one of Europe’s most modern biologics manufacturing sites. We provide client-tailored R&D, biologics process development, and GMP production of clinical and medium-scale commercial materials for biosimilar and biologics programs, supported by integrated QC, QA, and project management.
Innovative formulation
Our in-house capabilities include developing drug product formulations tested for stability per ICH guidelines. After internal development, processes can be scaled up and transferred to GMP-certified facilities or external partners.
Commercial-Scale GMP Biologics Manufacturing
One of Europe’s largest commercial-scale GMP biologics sites for commercial manufacturing and built for scalable biopharmaceutical production. FDA and EMA approved.
Warsaw-Duchnice, Poland
Located in Warsaw, Poland’s capital, our commercial-scale GMP biologics facility is one of Europe’s largest and newest. FDA and EMA approved for commercial manufacturing, it includes QC Labs for drug substance and is built to serve global demand for biologics and biosimilars.
Manufacturing expansion
The site adds significant drug substance manufacturing capacity at a 2,000L scale, plus single-use bioreactors from 50–500L for smaller batches. This enables cost-effective support for early-stage clinical trials and orphan drug production.
Partner with a European biologics CDMO dedicated to deliver program success
- Whether you’re advancing a novel biologic or planning for commercial scale, Rezon Bio is ready to help you move forward with confidence
- Connect with our team to explore how our expertise, integrated solutions, and dedication can accelerate your success