Manufacturing of new biotherapies risk analysis. Example of point of care manufacturing of CAR-T cells

The Laboratory of Cell and Gene Therapy (LTCG) linked to the hematology department of the CHU of Liege, is divided in 3 separate banks : Cord Blood , Hematopoietic Stem Cells and non-HSC bank which provides raw material for ATMP production (apheresis, bone marrow,…). Several ATMP (MTI) are manufactured in the lab such as Mesenchymal Stromal Cells or CAR-T. Taking CAR-T as an example, we will go through the different aspects of prevention of contamination in place in our facility: premises, equipments, circulation of materials and agents in the clean room, class B&C gowning, pratices in place for infectious agents, prevention of cross-contamination, cleaning, environmental monitoring and quality controls.