Translational Hub

Translational Hub – Translational BioHub for innovative therapies

Hosting Entity: Ozzano Technopole “Rita Levi-Montalcini”

Partners: Fondazione IRET (Managing Legal Entity); TransMed Research srl social enterprise; Nanotech Lab of the University of Modena-Reggio Emilia; JSB Solutions srl

Mission and Strategic Focus

The Translational BioHub aims to strengthen the development of innovative therapies by supporting the transition from preclinical research to early clinical validation. The Hub works with researchers, start-ups, and companies active in pharmaceuticals, biotechnology, and advanced therapies.
Its focus combines translational models, advanced therapeutic solutions, and regulatory-ready development.

CORE PILLARS:

Translational Disease Models:
- Develop in vitro and in vivo disease models based on clinically relevant models and end-point
- Enable PoC (Proof-of-Concept) studies for personalized medicine approaches.
Advanced Therapies and Nanomedicine:
- Design and test biological drugs, ATMPs (Advanced Therapy Medicinal Products), and nanomedicines
- Support targeted delivery and evaluation of efficacy and safety.
Regulatory Certifications: By GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) certifications the Hub supports the progression from TRL (Technology Readiness Level)2 to 6–7 (including clinical studies).

The Hub operates through joint research projects, shared infrastructures, regulatory guidance, technology transfer, training, and international collaboration.

IMPACTS:

Technological: very strong translational pipelines.
Economic/industrial: reduced R&D risk for companies.
Social/Sustainability: safer therapies for unmet medical needs.

Infrastructure

The Translational BioHub is hosted at the Bologna-Ozzano “Rita Levi-Montalcini” Technopole, part of the Emilia-Romagna High Technology Network. The infrastructure supports the full translational pipeline, from cellular systems to clinical laboratory studies.
Its facilities enable validation, safety assessment, and scalability of innovative therapies in a regulated environment.

KEY ASSETS:

Certified laboratories: in vitro and in vivo studies compliant with GLP principles.
Clinical laboratory: biomarker validation and analysis under GCLP (Good Clinical Laboratory Practice) principles.
Cell platforms: high-content screening based on human and animal cells in two-, three-, and four-dimensional disease models.
Animal facility: preclinical testing with digital records, biobank, surgery rooms, and automatic behavioral analysis.
Advanced microscopy: confocal, light-sheet, and high-content screening for quantitative imaging.
Nanomedicine platform: fabrication and characterization technologies aligned with regulatory standards.

Quality systems follow ALCOA (Accountable, Legible, Contemporary, Original, Accurate) and FAIR (Findable, Accessible, Interoperable, Reusable) principles.

OUR SERVICES

R&D and Innovation Support

Integrated innovation support combining the Bologna-Ozzano Technopole’s problem-solving and data management expertise with JSB Solutions’ regulatory, clinical trial, and clinical software capabilities
Design and characterization of regulatory- and industry-compliant “smart” nanomedicines targeting biological barriers, supported by the Nanotech Lab
Synergistic ecosystem accelerating R&D and technological transition in advanced biotechnological solutions.

Contractual Research Services

In vitro and in vivo PoC studies on clinically relevant models for drugs, biologics, ATMPs, and medical devices
Customization of experimental models with disease-relevant readouts and methodological standards
GLP-certified toxicity studies (including neurotoxicity) and regulatory reporting
GCLP-certified biomarker validation and dosing in human biological fluids for clinical studies.

Facility / Lab Access

Morphology, cell biology, molecular biology, and proteomics labs
Advanced microscopy and image analysis
Animal facilities.

Technology Transfer Services

Identification of TT (Technology Transfer)-ready projects from SMEs, startups, and research institutions
Regulatory-oriented pipeline simulation with TRL cost and time assessment
Regional coordination to showcase TT-ready results (Technopole Network, ART-ER, regional actors)
Patentability support, where applicable
Training on GxP standards and advanced methodologies.

Science communication

Promotion, dissemination and aggregation for the community and stakeholders via dedicated projects (Creating Conscious Networks; Recognise Your Brain – from deficit to benefit; Your Brain, Your Planet).

INTERNATIONAL COLLABORATIONS & PARTNERSHIPS

International collaborations enhance the Translational BioHub by expanding access to expertise, infrastructures, and coordinated research programmes. Partnerships support joint research, technology transfer, and scaling of innovative therapies, together with participation in European and national initiatives to increase the impact of translational activities.

KEY PARTNERSHIPS:

EBRAINS – European research infrastructure (Belgium)
- Focus: interoperable data, tools, and computing for brain research.
- Activities and outputs: integration of datasets and platforms through a formal agreement.
- Benefit for the Hub: access to shared European research resources.
European Technology Platform for Nanomedicine (Belgium), also via Italian Nanomedicine Platform (Italy)
- Focus: coordination of nanomedicine research and innovation.
- Activities and outputs: strategic roles in European and national platforms.
- Benefit for the Hub: alignment with European priorities in advanced therapies.
Brains for Brain Foundation (the Netherlands)
- Focus: rare pediatric neurodegenerative diseases and drug delivery to the central nervous system.
- Activities and outputs: joint development of innovative delivery strategies.
- Benefit for the Hub: acceleration of translational nanomedicine solutions.

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