The Centre for Manufacture of Advanced Therapies of Galicia (CTA) aims to manufacture ATMPs, for example CAR-T cells, adhering to a pharmaceutical quality management system based on Good Manufacturing Practices (GMPs).
The CTA services hospitals within the Galician Health System (SERGAS), but also other users requiring GMP-compliant infrastructure for development of ATMPs for clinical or pre-clinical studies.
The CTA was designed and built to meet EU standards and regulations for GMPs, so that therapeutic products may be manufactured under strict conditions of quality, safety and efficiency. The Centre also provides support for manufacture of therapeutics for research purposes with the aim to facilitate ATMPs reaching the clinic.
The CTA is located in the Monte da Condesa building, in Santiago de Compostela, with more than 800 sqm distributed in 6 production cleanrooms, a cryostorage room, quality control laboratories and simulation or research laboratories. The production cleanrooms are designed for either open manufacturing in class A safety cabinets or manufacture in single use closed bioreactors. The remaining laboratories are equipped for tissue culture and other techniques such as flow cytometry or RT-qPCR. Support areas include warehousing facilities, changing rooms and offices.
The centre and critical equipment are monitored 24/7 to ensure compliance with regulations.
