The Cell Therapy Production Unit has the facilities and equipment necessary for the production of advanced therapies-both cell therapy and gene therapy-in accordance with Good Manufacturing Practices (GMP). These mandatory standards guarantee the quality and safety of medicines intended for human use, both in clinical trials and once they have been authorized for marketing.

• Pharmaceutical quality system subject to favorable inspection by the Spanish Agency for Medicines and Health Products (AEMPS).
• MITECO authorization for the handling of genetically modified organisms: CAR-T cells

Our Cell Therapy Production Unit operates under a rigorous pharmaceutical quality system, duly certified and subject to favorable inspection by the Spanish Agency for Medicines and Health Products (AEMPS). We have state-of-the-art facilities and equipment specially designed for the aseptic production of cutting-edge cell and gene therapies-including CAR-T therapies, TILs, specific T lymphocytes, regulatory T lymphocytes, NK cells, and mesenchymal cells-with scalability, traceability, and control adapted to the highest standards. Our highly experienced team has carried out all the validation phases required by the AEMPS for the authorization of clinical trials with CAR-T therapies and specific T lymphocytes. Thanks to this comprehensive approach, our Unit is perfectly equipped to accompany the development of advanced therapies from design to clinical implementation, ensuring quality, safety, and regulatory compliance at every stage.

• Controlled environment facilities: two laminar flow cabinets in a grade B aseptic environment.

• CliniMACS Prodigy Bioreactor

Production

• CAR-T batch production.
• Specific T lymphocyte batch production.

Quality control

• Identity, purity, potency, and cell viability testing.
• Endotoxin, mycoplasma, and sterility analysis.

Scientific and technical consulting

• Development and transfer of processes from the research laboratory to the clinical scale: design and validation of the manufacturing process for advanced therapies on the CliniMACS Prodigy platform in accordance with GMP (CAR-T, TILs, specific T lymphocytes, regulatory T lymphocytes, mesenchymal cells, etc.).
• Design and development of strategies for environmental control in clean rooms.
• Validation protocols for analytical techniques in accordance with ICH Q2 (R2).
• Development and implementation of aseptic manufacturing validation plans in accordance with GMP (manufacturing simulations).
• Preparation of standard operating procedures (SOPs).