11 December, 2020

Guideline Cell Produciton (Preclinical Studies)

CREATIO PUBLISHES A GUIDELINE FOR CLINICAL-GRADE HEK293T CELL BANKING FOR LENTIVIRAL PARTICLE PRODUCTION

Creatio is a leading national center for the clinical production of advanced therapy medicinal products (ATMPs), such as cell and gene therapies and tissue engineering products. These therapies are currently used to treat diseases that were otherwise incurable or that presented very limited therapeutic possibilities. Creatio’s advanced therapy production platform has more than 300 m2 of clean rooms, apart from research laboratories and cryopreservation rooms, all located in the Faculty of Medicine and Health Sciences of the University of Barcelona. 

During the last years, Creatio has been implementing and continually improving various protocols that operate under Good Manufacturing Practices (GMP) for the production of viral vectors at the clinical level. Creatio produces lentivirus particles for various chimeric antigen receptor (CAR) T-based cell therapies, which have shown excellent results in the treatment of hematological tumors. Creatio currently produces lentiviral vectors for various hospitals, as well as research and production centers. 

The road to the successful manufacture of clinical-grade lentivirus begins with the generation of a master and working cell bank using the HEK293T line. For this reason, Creatio has published a comprehensive protocol for the expansion, cryopreservation and validation of HEK293T cells that operates under the GMP quality system. The work is led by Dr Unai Perpiñá, Creatio’s Qualified Person. The published guideline can serve as a reference for research centers, academic institutions and hospitals to generate a cell bank and later produce viral vectors ensuring the highest quality of the final product.