Periodic Reporting for period 1 - Vasc-on-Demand (Prefabricated Mature Blood Vessels and Tools for Vascularized 3D Cell Culture)
Periodo di rendicontazione: 2024-05-01 al 2025-04-30
Around 90% of all drug candidates fail during clinical trials, mostly due to a lack of efficacy in humans. A key reason for this is the limited predictive power of preclinical models: conventional cell cultures and animal testing can only approximate complex human physiology to a limited extent—particularly when it comes to blood circulation, immune responses, and drug distribution.
Vasc-on-Demand addresses this gap by developing standardized artificial blood vessels that are ready for immediate use and can be seamlessly integrated into existing workflows due to their compatibility with common formats—no additional equipment or modifications are required. These models enable realistic studies of cellular processes and drug effects under physiologically relevant conditions.
The unique selling point lies in the combination of human likeness and immediate availability. Unlike custom-built or individually developed solutions, these vascular models offer a standardized, reproducible platform for preclinical testing.
By using such models, drug development can become more efficient. More reliable preclinical data leads to better decision-making, lowers development costs, and increases the likelihood of successful clinical trials—with the ultimate goal of bringing effective therapies to patients more quickly.
This project directly addresses a critical bottleneck in the global pharmaceutical development pipeline and aligns with strategic efforts to reduce reliance on animal testing (e.g. the EU’s directive 2010/63/EU). By providing standardized, physiologically relevant vascular models, Vasc-on-Demand contributes to regulatory innovation and faster translation of therapies to market. Given the scale of attrition in drug development, even a modest improvement in preclinical prediction could lead to significant economic savings and patient benefit.
In parallel, significant progress was made in the development of the platform technology consumable. The modular design was refined through prototyping and simulation, optimizing it for injection molding and standardization. A major step was the redesign from additive manufacturing to formats compatible with common lab tools, such as well plates and microscope slides. Injection molding simulations were performed, and initial testing with a benchtop machine was conducted.
Scaffold production was transitioned from additive manufacturing to vacuum casting, improving scalability, cost-efficiency, and reproducibility. This method enables the generation of biologically relevant structures in a production-stable manner. External testing with academic partners is ongoing.
The first prototypes resembling the envisioned final product were produced and characterized for biomedical usability by testing several matrix formulations at varying concentrations. A key outcome was the formation of a confluent endothelial layer, confirmed by immunofluorescence staining and functional validation to assess barrier function and open, perfusable channels. This indicates proper cell-cell contact and cytoskeletal integrity, consistent with a mature endothelial phenotype.
These results are supported by accompanying protocols and manuals. Samples were distributed to initial partners and pilot users for testing and feedback. These developments lay the foundation for subsequent internal product iterations and market preparation.