The Pharmaceutical Workshop of Bambino Gesù Hospital is dedicated to the formulation of cell and gene therapy products in the context of advanced therapies (ATMPs – Advanced Therapy Medical Products) according to Good Manufacturing Practices (GMPs). Established in the research laboratories in the building of San Paolo Fuori le Mura, the Unit covers an area of approximately 1,400 square meters, which makes it the largest academic GMP facility in Italy.
In 2020, it was inspected by AIFA (the Italian Medicines Regulatory Agency) that approved the new remodeled structure of the production area, that now includes eight processing rooms for products genetically modified with viral vectors, and one room for the extensive processing of cell products. In 2020, the Unit took part in a clinical trial on mesenchymal stromal cells (MSCs), and in three clinical trials on CAR-T cells.
Importantly, the Unit carried out the technological transfer of two new CAR-T therapy products, one of which for the use of an automated platform for the production of CAR-T cells using a lentiviral vector for the expression of the CAR.CD19 receptor. The Unit also developed a CAR-T product dedicated to patients with non-Hodgkin’s lymphoma, mediastinal lymphoma, anaplastic large cell lymphoma and cutaneous T-cell lymphoma.