Clinistem - BioInn
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/041I/22) 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.
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 Gene Therapy Production Manager, a Cell Therapy Production Manager, a Quality Control Manager, a Quality Control Supervisor, a Quality Control Technician and a Quality Assurance Manager, distributed according to the following organization: