Biomedical Innovation Researchers producing an Advanced Therapy drug in the GMP production facility


The GMP CliniStem facility is prepared for the elaboration of Advanced Therapy products under Good Manufacturing Practices (GMP), for conducting clinical trials.

CliniStem has been certified (Certificate Number: ES/080I/23) by the Spanish Medicine Agency for the manufacture of the following Advanced Therapy medicines in the research phase:

  • Autologous peripheral blood stem adult CD34+ hematopoietic cells not expanded transduced with lentivirus.
  • Autologous adipose stem adult mesenchymal cells expanded.
  • Allogeneic adipose stem adult mesenchymal cells expanded.
  • Autologous peripheral blood differentiated adult T lymphocytes expanded genetically modified by trasposons in order to express a chimeric antigen receptor (CAR) anti-CD19 and a truncated receptor (EGFR).

The laboratory consists of a GMP Clean Room, classified as grade B and two laminar flow cabinets, classified as grade A. In addition, CliniStem has among its facilities a Quality Control laboratory and a Cryopreservation laboratory. All the classified areas and CliniStem equipment are annually qualified to verify their correct functionality.

The GMP laboratory staff is made up of a Technical Manager, a Production Manager, a Production Supervisor, a Quality Control Manager, a Quality Control Supervisor, a Quality Control Technician and a Quality Assurance Manager, distributed according to the following organization:

Clinistem Organizational Chart