ExCell Bio Achieves World-Leading EDQM CEP Certification for Fetal Bovine Serum

ExCell Bio Achieves World-Leading EDQM CEP Certification for Fetal Bovine Serum

ExCell Bio, a global leader in life science reagents, announces that its Uruguay-based fetal bovine serum (FBS) production facility, ARTICA, has been granted the Certificate of Suitability (CEP) by the European Directorate for the Quality of Medicines & HealthCare (EDQM). This milestone signifies ExCell Bio’s entry into the world-leading tier of CEP-certified FBS producers, demonstrating its commitment to pharmaceutical excellence and reinforcing its position at the forefront of global biotech quality standards.

Why This World-Leading Certification Matters

The CEP certification is internationally recognized as a "golden passport" for biologics entering regulated markets. ExCell Bio’s certification validates:

Global Compliance: Full alignment with European Pharmacopoeia (EP) specifications for identity, purity, and biosafety, exceeding routine international requirements.

End-to-End Quality Assurance: Rigorous EDQM audits covering traceability, GMP adherence (ICH Q7), and TSE risk control—elevating industry benchmarks.

Empowering Global Scientific Innovation

As a critical cell culture component, ExCell Bio’s CEP-certified FBS enables breakthroughs in:

Vaccines & Therapeutics: Supports GMP-compliant production of antibodies, cell/gene therapies, and regenerative medicines.

Reproducible Research: Ultra-low endotoxin levels (<0.2 EU/mL) ensure data integrity for academic and industrial R&D.

Supply Chain Resilience: Combines ExCell Bio’s vertically integrated supply chain—from Uruguay-sourced raw materials to global distribution—with localized technical support.

A Legacy of Global Leadership

With 19 years of expertise in serum production since 2006, ExCell Bio has redefined their role in the global biologics supply chain. As member of the International Serum Industry Association (ISIA) and now a world-leading CEP-certified FBS producer, the company exemplifies the ascent in high-end biomanufacturing.

About ExCell Bio
ExCell Bio is a globally recognized innovator in cell culture reagents and diagnostic solutions. Its portfolio—spanning FBS, serum-free media, and assay kits—powers biopharmaceutical development and academic research across 20+ countries. With GMP-compliant facilities in China and Uruguay, ExCell Bio ensures ethical, traceable, and high-performance products. Learn more at www.excellbio-artica.com.