Central Support Units for Biomedical Research

Cell Therapy Unit (CTU)

IMIBIC has a Cell Therapy Unit (CTU) comprising two specialised facilities for the manufacture of innovative medicines, known as Advanced Therapy Medicinal Products (ATMPs) for human use. These include somatic cell therapy medicinal products, tissue engineering and gene therapy. In addition, it has a dedicated cryopreservation area and an independent Quality Control laboratory accredited by the relevant authorities to work with Genetically Modified Organisms (GMOs), ensuring compliance with the required standards of safety, quality and traceability for these medicinal products.

The UTC facilities are equipped with advanced environmental control systems that ensure high-quality air and prevent any risk of cross-contamination, and are organised into two separate areas. On the one hand, the Cell Therapy Cleanrooms (SBTC), comprising a set of nine rooms classified from Grade D to Grade A (Pre-GMP, Storage, Dirty Changing Room, Clean Changing Room, Distribution Room, Production 1, Production 2 and Production 3) with a total area of 57.93 m², intended for the manufacture of cell therapy MTAs and tissue engineering. In addition, the Gene Therapy Cleanroom (SBTG) comprises a Grade C production room and two changing rooms with a total area of approximately 35 m². This is where gene therapy medicinal products are manufactured.

All areas are equipped with the necessary infrastructure to carry out the activities conducted there (biosafety cabinets, microscopes, centrifuges, balances, CO₂ incubators, refrigerators, freezers, ultra-low temperature freezers, amongst others). In addition, these facilities are equipped with automated platforms for the production of medicines in a closed system (CliniMACS Prodigy® or Sepax C-PRO). Both the facilities and critical equipment are monitored 24 hours a day to track and control their conditions, ensuring that they remain within the permitted and validated ranges at all times.

All UTC activities are carried out in accordance with the Pharmaceutical Quality System of Good Manufacturing Practices (GMP), which is governed by European Regulation EudraLex Volume 4, specifically Part IV, “GMP requirements for Advanced Therapy Medicinal Products”, and is authorised by the Spanish Agency for Medicines and Health Products (AEMPS) to manufacture various medicinal products.

Figure 1. Production Room in the Cell Therapy Cleanroom
Figure 2. CliniMACS Prodigy® in the Production Room of the Gene Therapy Cleanroom
Figure 3. Equipment in the Production Room of the Gene Therapy Cleanroom
Figure 3. Flow cytometer in the UTC Quality Control Laboratory
Figure 4. Equipment in the UTC Quality Control Laboratory