FDA Approval Granted for Commercial Manufacturing at Rezon Bio's Warsaw-Duchnice Facility

Rezon Bio announces that its Warsaw-Duchnice facility has received approval from the U.S. Food and Drug Administration (FDA) for the commercial manufacturing of a biosimilar. This milestone represents an important step in the continued development of Rezon Bio’s global manufacturing network and reflects the company’s focus on building robust, compliant, and reliable capabilities to support biologic therapies for patients worldwide.

The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and reflects the maturity of the site’s quality systems, technical capabilities, and operational readiness for commercial supply to the US market. This approval is coming subsequent to previous EMA GMP certification and approval for commercial supply to European markets. Such approval further strengthens Rezon Bio’s ability to support clients in needs to supply EU and US territories and enhances its position as a reliable partner within the Contract Development and Manufacturing Organization (CDMO) landscape.

“This milestone reflects the dedication of our teams to quality, collaboration, and scientific excellence,” said Adriana Kiędzierska-Mencfeld, CEO of Rezon Bio. “The FDA approval of our Warsaw-Duchnice site demonstrates our commitment to meeting applicable international quality and regulatory requirements and the ability to deliver reliable, world-class CDMO services. This achievement opens new possibilities for Rezon Bio and our partners, validating our position within the global CDMO sector as we continue to support clients in bringing critical biologic therapies to market”.

“From a quality perspective, this approval confirms the robustness of the systems, processes, and culture established at our Warsaw-Duchnice site,” said Abdelkader Talha, Vice President Quality at Rezon Bio. “Our focus remains on consistent execution, continuous improvement, and maintaining active engagement with regulatory authorities as we support our partners’ biologics programs”.

Sjouke Hoffman, Site Head at Warsaw-Duchnice, added: “This approval reflects the disciplined work of our teams in establishing robust processes and operational readiness at the Warsaw-Duchnice site. Our infrastructure and multidisciplinary expertise enable us to support both clinical and commercial biologics programs with consistent execution and in alignment with applicable quality and regulatory standards. We are proud to deliver innovative, scientifically robust and reliable solutions for our clients and support the development and availability of high-quality therapies for patients worldwide”.

Rezon Bio’s Warsaw-Duchnice site is a state-of-the-art biologics manufacturing and development center, offering integrated services from early development through commercial production. The multidisciplinary team includes experts in process and analytical development, GMP manufacturing, quality control, and regulatory affairs, ensuring project continuity and reliable delivery of high-quality biologic therapies.

Rezon Bio remains committed to supporting clients worldwide in bringing innovative biologic therapies to market safely, compliantly, and cost-efficiently.

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, with state-of-the-art facilities, world-class teams, and a proven track record of regulatory and commercial success. Grounded in Polpharma Biologic’s legacy of excellence in biosimilars development and manufacturing, Rezon Bio is committed to delivering value without compromise through innovation, collaboration, analytical excellence, and dedication to patients worldwide.

For more information about Rezon Bio’s facilities, please visit: https://rezonbio.com/discover/our-facilities/.

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