PBL offers an Exclusive Look into the Future of Advanced Biopharmaceutical Manufacturing

15 October 2025, Parma — Italy continues to assert its leadership in the global biopharmaceutical landscape with an introduction of PBL Pharma Division’s Cell Factory Box (CFBox), the world’s first customizable, robotized isolator designed for the production of Advanced Therapy Medicinal Products (ATMPs). Developed through a public–private partnership between PBL and the Ospedale Pediatrico Bambino Gesù (OPBG), and supported by €3.8 million in funding from the National Center under the PNRR framework, the CFBox represents a new chapter in the nation’s journey toward next-generation therapies.

With a collaborative vision for advanced therapies, the CFBox is an example of how industrial expertise and academic excellence can merge to create transformative technologies that reflects a collective broader goal of accelerating the translation of scientific discoveries into real-world medical applications.

According to Concetta Quintarelli, Head of the Tumor Gene Therapy Laboratory at OPBG, CFBox is not only a technological breakthrough but also a model for a more inclusive, flexible, and accessible system for manufacturing personalized medicines. It allows for the simultaneous production of multiple cell or gene therapy batches thus, drastically reducing time and costs while maintaining the highest standards of quality and sterility.

One of the most striking aspects of CFBox is its ability to operate efficiently in lower-grade cleanrooms such as Class D (ISO 8) or even Controlled Non-Classified (CNC) environments. Cleanrooms are highly controlled environments where the concentration of airborne particles is strictly regulated. Such facilities are essential in pharmaceuticals industries to ensure that highly sensitive products remain uncontaminated and safe. By enabling advanced manufacturing in these lower-grade environments, CFBox reduces the reliance on ultra-high-class facilities that are costly to build and maintain. This design not only expands access to cutting-edge production but also supports the decentralization of manufacturing that allow hospitals, research centers, and smaller biotech companies to produce ATMPs locally and sustainably.

In this context, CFBox was designed to meet and even exceed current GMP expectations. Its enclosed, robotized isolator minimizes human contact with materials, ensuring repeatable and verifiable production conditions. Its upcoming validation by OPBG researchers will take place at PBL’s advanced facility in Potenza (region of Basilicata), which coincides within the National Center’s broader mission to strengthen technological and research infrastructure in Southern Italy. This milestone not only advances the path toward AIFA approval for clinical use but also demonstrates how strategic investments in southern regions are helping to create a balanced, innovation-driven national network for advanced therapy manufacturing.

Beyond its technical achievements, CFBox embodies a new paradigm in how Italy approaches the manufacturing of advanced therapies. By merging industrial innovation with public health goals, the project aims to make life-changing treatments more widely available across the country and beyond.

Its decentralized model empowers institutions to produce cell and gene therapies closer to patients, reducing logistical barriers and improving responsiveness to urgent medical needs. With its modular design, low energy demand, and scalable architecture, CFBox paves the way for sustainable, equitable access to precision medicine.

By blending scientific insight with engineering excellence, PBL’s CFBox demonstrates the power of collaboration between public and private sectors. As one of the founding members of the National Center, PBL exemplifies how targeted investment and innovation can position Italy at the forefront of global biopharmaceutical progress.