Produzione di microparticelle Spray Dried con Secretoma da cellule Mesenchimali per la Rigenerazione Polmonare e il wound healing

The PROMISE project stands at the forefront of biotechnological and pharmaceutical innovation, employing two pioneering technologies not yet available in this form on the market: a high containment spray dryer designed to process highly potent or highly sensitive to contamination pharmaceutical substances, and the application of mesenchymal stem cells secretome in medical products. PROMISE uniquely integrates these elements, drawing on the expertise of partners within the Interreg region to achieve two main objectives: 1) create high-performance pharmaceutical substances validated for inclusion in new drug formulations intended to treat pulmonary and wound healing diseases; and 2) validate an innovative spray-drying process conducted in a protected atmosphere to ensure the highest quality of powder product while minimizing contamination risks. These dual innovations converge in PROMISE, offering a powerful combination to tackle market challenges. In recent years, advancements in drug delivery and targeting systems have aimed to optimize therapeutic effectiveness by improving bioavailability, reducing drug degradation rates, and controlling the release and cellular absorption of therapeutic agents. Concurrently, mesenchymal stem cell treatments have gained prominence in regenerative therapies. Numerous studies have indicated that their therapeutic effects derive not from their differentiation potential but from the release of biologically active substances—soluble and encapsulated in vesicular structures like microvesicles and exosomes, collectively known as the “secretome”. Beyond these findings, the secretome offers significant advantages for regenerative pharmaceutical treatments, including ease of administration, reduced oncogenic concerns compared to direct stem cell use, and lack of immunogenic response, facilitating allogeneic or ready-to-use therapies. PROMISE is focused on producing an innovative powdered drug containing secretome to enhance delivery and targeting in treating pulmonary diseases and regenerative skin medicine. The powder is produced using the second innovation in PROMISE: a high containment spray dryer confined under an isolator. This setup minimizes product contamination, drastically reduces cross-contamination risks, ensures operator safety, and limits powder dispersion in the surrounding environment. This technology enables the production of sterile, high-quality therapeutic products meeting stringent regulatory standards for new drugs. Once validated, this technology promises wide applicability across various pharmaceutical domains, especially in producing high-potential drugs, which are typically manufactured in expensive, strictly controlled environments. PROMISE introduces a 'plug and produce' technology that is easy to install and can operate effectively in non-sterile production settings, significantly reducing production costs and facility requirements. Achieving these results relies on the combined expertise from both sides of the Italy-Switzerland (IT-CH) Interreg border. Production technology developers primarily from Ticino (Schedio) work alongside Piedmont-based APTSol and UPO, which test the technology using the secretome in a form patented by PharmaExceed. This synergy is further enhanced by exploring in both the production technology and pharmaceutical ingredient from numerous pharmaceutical companies in Ticino and hospitals in both regions, facilitated by ORIENTO. Through PROMISE, we aim not only to advance scientific and technological development but also to foster significant economic growth and innovation across the Italy-Switzerland border. The collaborative efforts among Italian and Swiss partners are instrumental in addressing complex challenges and expanding the boundaries of what is possible in the medtech and pharmaceutical industries. The project also facilitates essential exchanges of knowledge, best practices, and access to cutting-edge research infrastructures. This transnational cooperation ultimately supports the development of more effective and competitive healthcare solutions, promoting scientific advancement and enhancing community health outcomes across the regions.