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

3 October 2024

Dr Chantal Le Chanteur, Liège University Hospital, Belgium

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.

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