---
name: Rezon Bio
slug: rezonbio
site: cdmo
website_domain: rezonbio.com
summary: European biologics CDMO offering end-to-end development and manufacturing across two GMP-certified sites in Poland, with capabilities spanning cell line development, process development, analytical testing, and commercial-scale GMP manufacturing up to 2,000L bioreactors. Headquartered in Poland, Poland.
tagline: European biologics CDMO with end-to-end GMP manufacturing and development across two certified Polish sites.
founded_year: 
employee_count_band: 1001-5000
employee_count_label: 1,001–5,000
parent_name: 
parent_slug: 
hq_country: PL
tier2_domain_verified: false
updated_at: 2026-10-05T07:03:10.538Z
services_count: 8
modalities_count: 2
indications_count: 0
locations_count: 2
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Rezon Bio

European biologics CDMO with end-to-end GMP manufacturing and development across two certified Polish sites.

Listed on cdmo.directory.

## Summary

European biologics CDMO offering end-to-end development and manufacturing across two GMP-certified sites in Poland, with capabilities spanning cell line development, process development, analytical testing, and commercial-scale GMP manufacturing up to 2,000L bioreactors. Headquartered in Poland, Poland.

## At a glance

- Employees (est.): 1,001–5,000
- HQ country: PL

## Services

- Cell-Line Development
- Process Development
- Upstream Processing
- Downstream Processing
- CMC Analytical Development
- Technology Transfer
- Quality Control Testing
- Regulatory Affairs

## Modalities

- Biologics (Monoclonal Antibodies)
- Biologics (Other)

## Locations

- Clinical Development & Manufacturing, Poland, Poland
- Commercial Scale Manufacturing, Poland, Poland

## Certifications

- EMA; Identifier: EMA approved; Source: https://rezonbio.com/
- FDA; Identifier: FDA approved; Source: https://rezonbio.com/

## Long description

## 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

## Related companies

- [WuXi Biologics](/companies/wuxibiologics) (Cell-Line Development, Process Development) — [Compare](/compare/rezonbio/wuxibiologics)
- [Avid Bioservices](/companies/avidbio) (Cell-Line Development, Process Development) — [Compare](/compare/avidbio/rezonbio)
- [Validogen](/companies/validogen) (Cell-Line Development, Process Development) — [Compare](/compare/rezonbio/validogen)
- [Bionova Scientific](/companies/bionova-scientific) (Cell-Line Development, Upstream Processing) — [Compare](/compare/bionova-scientific/rezonbio)
- [Celonic](/companies/celonic) (Cell-Line Development, Process Development) — [Compare](/compare/celonic/rezonbio)
- [KBI Biopharma, Inc.](/companies/kbibiopharma) (Cell-Line Development, Process Development) — [Compare](/compare/kbibiopharma/rezonbio)
- [WuXi Vaccines](/companies/wuxivaccines) (Cell-Line Development, Process Development) — [Compare](/compare/rezonbio/wuxivaccines)
- [Bailun Biotechnology Co., Ltd.](/companies/fermentorchina) (Process Development, Upstream Processing) — [Compare](/compare/fermentorchina/rezonbio)

_Profile last updated: 2026-10-05T07:03:10.538Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.