Rezon Bio

Overview

Rezon Bio is a European biologics contract development and manufacturing organization (CDMO) specializing in cost-efficient, scalable solutions for biologics programs. The company operates two GMP-certified facilities in Poland and provides integrated services from early development through commercial manufacturing.

Core Capabilities

Development Services:

• Process development and characterization for upstream and downstream biologics processes
• Scalable processes optimized for biosimilars and new biological entities (NBEs) from lab to commercial scale
• Analytical capabilities with phase-appropriate, method-qualified testing for product quality and release
• Cell line development

Manufacturing & Scale-Up:

• GMP manufacturing at clinical and commercial scale
• Two facilities: clinical development and medium-scale manufacturing center, plus large state-of-the-art commercial-scale facility with 2,000L bioreactors
• Technology transfer, MSAT (manufacturing scale-up assessment), and PPQ (process performance qualification) expertise
• Strategic partnerships for fill/finish enabling "ready to fill" solutions

Quality & Regulatory:

• Quality systems aligned with regulatory requirements
• FDA and EMA inspection-ready facilities
• Successful track record: 35+ audits passed (EMA, FDA, MHRA, ANVISA)
• 97% batch success rate (2024–2025)
• 12 technology transfers completed since operations began

Organization

• Workforce: >1,100 employees; 80% hold higher education degrees; 10% hold PhDs; 22 nationalities represented
• Experience: >13 years of biologics development and manufacturing operations
• Production: 137 batches produced since 2024
• Regulatory Approvals: FDA and EMA approved; passed audits from MHRA and ANVISA