A Sala Blanca (White Room) or Clean Room is a room specially designed to work at minimal or no levels of contamination. These rooms must meet Good Manufacturing Practices (GMP) in order to be authorised for drug manufacturing.
These standards are specific quality requirements for drug manufacturers. The implementation of the quality management system affects personnel, premises and equipment, the documentation system, production processes, quality control, product recalls and inspections.
The following manufacturing processes are authorised by the AEMPS:
- Adult allogeneic/autologous mesenchymal bone marrow stem cells: isolation and expansion.
- Adult allogeneic/autologous mesenchymal adipose tissue stem cells: isolation and expansion.
- Differentiated adult allogeneic Natural Killer peripheral blood cells stimulated with IL-15: isolation and activation.
- Differentiated adult allogeneic/autologous Natural Killer peripheral blood cells cocultivated with cell line K562: isolation and activation.
- Adult allogeneic mesenchymal adipose tissue stem cells: isolation and expansion in fibrin matrix.
- Expanded allogeneic foetal mesenchymal umbilical cord stem cells.
- Expanded autologous adult tumour infiltrating lymphocytes (TILs) stem cells.
- Expanded autologous adult peripheral blood endothelial progenitor cells (EPCs).