Located in Barcelona—one of Europe's leading hubs for clinical research and clinical trial activity—this 720 m² facility integrates GMP manufacturing, analytical quality control, and controlled storage under one roof, supporting biologics and immunotherapeutic products from development through clinical batch release.
Key Capabilities
- Aseptic Processing (Annex 1): Grade C/B cleanrooms equipped with oRABS and Grade A unidirectional airflow for sterile liquid filling and lyophilized product manufacturing. Terminal sterilization is also available.
- Lyophilization: Lyobeta 20 freeze dryer supporting both cycle development and GMP batch production.
- GMP BSL-3 Biocontainment: A 36 m² Grade B facility for handling Group 3 biological agents, representing one of the few GMP-certified BSL-3 suites in Europe available to external partners.
- BSL-2 & GMO Capabilities: Dedicated facilities for viral vectors and GMO-based biologics, supported by the appropriate regulatory framework.
- GMP QC Analytical Laboratory: Comprehensive in-house quality control services to verify the safety, identity, purity, and potency of every batch prior to release.