GE-Healthcare closed cell processing system, incl. attributes
Status: in use
Registration: no open registration. Please contact Monique de Beijer.
Monique de Beijer
The GE Healthcare closed culture system enables fully automatic, Good Medical Practice (GMP)-compliant culture of Advanced Therapy Medicinal Products (ATMPs). These immune cell ATMPs are based on (genetically modified) T cells or dendritic cells. This innovative, closed system allows us to scale up and standardize current ATMP production with less manpower and a decreased risk of contamination. This facilitates a more efficient and cost-effective workflow and a more reproducible quality of the therapeutic product, which is deemed necessary for the increased volume of immune cell ATMPs that the Erasmus MC aims to produce.
The system consists of:
– Terumo tubing system. The TSCDII tube welder is a compact, portable device that in a sterile manner seals together two tubes (such as tubes from culture and/or medium-containing bags) thereby guaranteeing that the culture system is and remains closed.
– Miltenyi CliniMACS Prodigy. The Prodigy allows for automation and standardization of the entire production process, including (when necessary) activation and purification of defined immune cell populations.
– Cytiva Xuri Cell expansion. The Xuri facilitates the scaling-up of individual immune cell cultures, thereby resulting in high cell yield per culture bag.