BST’s Advanced Therapies Manufacturer receives gene therapy certification under Good Manufacturing Practices

The Spanish Agency of Medicines and Medical Devices (AEMPS) has certified the Advanced Therapies Manufacturer of the Blood and Tissue Bank with gene therapy certification under Good Manufacturing Practices (GMP), which means the Blood and Tissue Bank is now authorized to manufacture CAR-T therapy.

This certification is granted for the manufacture of adult autologous peripheral blood-derived T lymphocytes, expanded and transduced using a retroviral vector. It strengthens BST's position in the production of advanced therapy medicinal products and adds to our existing authorization for cell therapy products:

• Expanded adult autologous mesenchymal stem cells derived from bone marrow

• Expanded and cryopreserved allogeneic mesenchymal stem cells from Wharton's jelly (umbilical cord)

• Non-expanded allogeneic differentiated adult T lymphocytes from peripheral blood, stimulated with specific peptides

• Non-expanded adult autologous CD133+ stem cells from peripheral blood

• Expanded differentiated adult autologous tumor-infiltrating lymphocytes (TILs)

This milestone marks a decisive step in the development of advanced therapies and reinforces our commitment to biomedical innovation and the development of personalized therapeutic solutions for patients.