Research and development
Since its foundation in 2002 as a spin-off of the University of Urbino, Diatheva has consistently invested in research and development activities. These efforts span both proprietary products and successful participation in numerous national and European research projects, progressively expanding our network of collaborations with public and private institutions and enriching our technical know-how.
Diatheva’s R&D laboratories play a pivotal role in supporting both internal functions and external stakeholders such as clients and institutions.
Internally, our R&D laboratories are dedicated to:
- Basic and translational research: The labs drive Diatheva’s innovation by focusing on the discovery of new biological therapies, especially in oncology and infectious diseases. This includes identifying new therapeutic targets and developing recombinant proteins and antibodies.
- Diagnostic product development: Diatheva specializes in the design, development, validation, and production of molecular and immunoenzymatic kits for clinical, veterinary, food, and environmental diagnostics.
- Biotechnological process development: Our labs handle the early phases of biotech development, focusing on the design and optimization of production processes to ensure robustness and scalability for efficient tech transfer to GMP production units.
- Quality control: Quality control laboratories are essential to ensure that Diatheva’s developed, manufactured, and packaged products meet the highest internationally recognized quality standards.
For external partners, our R&D labs offer a wide range of services, including:
- Development of custom diagnostic assays: Diatheva collaborates with companies and research institutions to develop tailored diagnostic tools. Services include design, feasibility studies, development, validation, and production.
- Production of custom antibodies and proteins: We provide custom production services for monoclonal and polyclonal antibodies, as well as recombinant proteins for clients needing high-quality reagents for research or development purposes.
- GMP manufacturing services: Diatheva offers GMP infrastructure and expertise to support biotech and pharmaceutical companies in producing biologics for preclinical and clinical studies. This includes cell line development, GMP production, and regulatory support.
- Regulatory support: Diatheva assists clients with the preparation of regulatory documentation required for approval of diagnostic and biopharmaceutical products, streamlining the submission process.
Diatheva’s laboratories are strategically organized to best support both internal research, development, and production efforts, as well as specialized services for external partners. They are divided as follows:
- Biochemistry laboratory: Dedicated to the characterization of biomolecules (proteins, antibodies, DNA, RNA), development of biochemical assays, and analysis of molecular interactions—key activities for target discovery, diagnostic development, and production process optimization.
- Microbiology laboratory: Focused on fermentation process management and optimization, including the selection and cultivation of microorganisms and performance monitoring. Activities also cover the expression of recombinant proteins and enzymes using microbial expression systems.
- Cell culture laboratory: Supports production processes using mammalian cells through selection, cultivation, and controlled growth. The lab is used for the production of cell lines, monoclonal antibodies, and cell-based assay development.
- Purification laboratory: Handles the isolation and purification of recombinant proteins using various techniques. It also supports production process optimization for proteins, enzymes, and antibodies, which are later transferred to the GMP production unit.
- Molecular biology laboratory: Manages sample preparation, nucleic acid extraction (RNA/DNA), and amplification using PCR, RT-PCR, and qPCR. It also supports the development and validation of diagnostic tests for infectious diseases, genetic disorders, and specific biomarkers. Tests undergo rigorous validation to ensure maximum diagnostic performance in terms of reliability, specificity, and sensitivity.
- Production areas: Primarily dedicated to the manufacturing of molecular and immunoenzymatic kits for clinical, veterinary, food, and environmental diagnostics.
The layout of Diatheva’s labs is strategically designed to ensure an efficient workflow and the availability of the right skills and tools for both in-house R&D and production, as well as external service delivery. Each area performs a specific function that contributes to the overall success of our company operations.
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