Histocell, S.L.

Histocell is a regenerative medicine biopharmaceutical company CDMO with extensive experience in developing and manufacturing cell-based therapies and novel medical devices.

Spain-based clinical stage CDMO, located in the biohealth ecosystem of the Basque Country.

Together with the Basque Health Cluster, Histocell is part of an innovative cell and gene therapy ATMPs manufacturing hub.

What do we manufacture?

• Autologous and allogeneic mesenchymal stem cells (MSC).
• Other types of cells: epithelial cells, chondrocytes, blood cells…
• Induced pluripotent stem cells (iPSC).
• Cell banks and stocks.
• Sterile products.
• Secretomes of different cell types.
• Exosomes (R&D).
• CAR-T and NK cells (R&D).

Facilities

• Authorised pharmaceutical laboratory (MIA: 4269E).
• Facilities for the manufacture of cell therapy drugs or derivatives, such as secretomes.
• Designed to carry out development, pre-clinical and clinical phases, and ready to take on the manufacture of drugs that reach the commercial phase.
• Fully equipped rooms for the manufacture, control and release of autologous and allogeneic therapies.
• GMP manufacturing rooms for scale-up of autologous therapies (rooms for simultaneous processing) and allogeneic therapies (rooms for large cell banks and stocks), and associated infrastructures.
• Quality services and procedures for the manufacture of clinical grade material.

Services

• Development and optimisation of processes.
• Development and validation of analytical methods.
• Scale-up of allogeneic and autologous processes.
• Manufacture of clinical grade intermediate and final products.
• Manufacture of cell banks (stocks).
• Fill & Finish.
• Quality control and release.
• Storage and cryopreservation.