OncoGen - "Pius Brînzeu" Emergency County Clinical Hospital Timișoara

The OncoGen Center (Center for Gene and Cellular Therapies in Cancer) is an advanced research and hospital-based bioprocessing facility integrated within the Pius Brînzeu County Clinical Emergency Hospital (SCJUPBT) in Timișoara, Romania. Embedded in a leading tertiary university hospital, OncoGen combines fundamental and translational research with point-of-care manufacturing capabilities for cell and gene therapies.

Core Infrastructure & Bioprocessing Capabilities

• Advanced Cleanroom Complex: 160 m² facility with 2 × 12 m² Grade A workstations in Grade B background cleanrooms, a 20 m² BSL-2 area, and surrounding Grade C and D support zones. National regulatory authorization for clinical-scale ATMP manufacturing is currently in progress.

• Automated Closed-System Manufacturing: Operational Miltenyi CliniMACS Prodigy platform for standardized, closed-system cell separation, genetic engineering, and formulation.

• Analytical & Quality Control Suites: Flow cytometry suites (multi-parametric immune profiling), genomics/NGS, proteomics, HLA typing, biobanking, confocal imaging, and dedicated quality-control laboratories.

• Preclinical Platform: In vivo experimental animal facility and BSL-2 laboratories for translational validation and toxicology.

Integrated Clinical Ecosystem

Being co-located with SCJUPBT’s clinical departments provides immediate access to:

• Access to clinical hematology, medical oncology, and clinical immunology through established partnerships with leading tertiary university hospitals and oncology institutes.

• A dedicated therapeutic leukapheresis unit for starting material collection.

• Access to clinical hematology, medical oncology, and clinical immunology through established partnerships with leading tertiary university hospitals and oncology institutes.

• Intensive care units (ICU) prepared for post-infusion toxicity monitoring and specialized management.

• A comprehensive human cell and tissue biobank.

R&D and Intellectual Property Focus

OncoGen develops next-generation cellular immunotherapies, including:

• Chimeric Antigen Receptor (CAR) cell platforms: CAR-PBMC and CAR-NK platforms directed against solid tumor targets (EGFR, HER2).

• Exosome-based, cell-free targeted therapeutics.

• Proprietary patent portfolio covering universal chimeric receptors and bispecific CAR-T architectures.

Contribution to European Collaborative Projects (Horizon Europe & IHI)

As a fully equipped site located in a Widening (CEE) country, OncoGen offers consortia:

1. Manufacturing Readiness Validation: Real-world piloting of automated closed-system platforms, environmental monitoring, and release-testing SOPs during the transition to full GMP accreditation.

2. Clinical Centre Readiness: Co-development and validation of harmonized clinical pathways (standardized apheresis, cold-chain logistics, and post-infusion management) integrated with affiliated oncology and hematology networks.

3. Regulatory & Health Economics Data: Documented case studies and real-world capacity/cost-of-goods models for decentralized hospital-based manufacturing and hospital exemption pathways.

Collaboration Profile:
We are open to partnerships with pharmaceutical and biotech leaders, academic coordinators, clinical networks, and technology developers preparing collaborative proposals under IHI (specifically Call 14) and Horizon Europe Cluster 1 Health.