Establishing a suitable manufacturing process, profitable, consistent and robust is the ultimate goal pursued by manufacturers of ATMPs. There’s a variety of culture media supplements used to promote in vitro proliferation of cells. Fetal Bovine Serum (FBS), of xenogeneic source, has been traditionally used as main supplement medium; however, this trend has been changing in the last years to introduce non-xenogeneic source components such as human Platelet Lysate (hPL) or human AB Serum (HS).
The type of culture medium supplement and its proportion in the complete medium is established by the manufacturers. The “profitability” of the growth promotion medium is understood in this context as the “number of cells recovered” and the “cell doublings”. These parameters are not easy to assess since there are many other factors that directly impact on them, as the type and status of the cell donor or incubation and expansion condition, among others.
Participants subscribed to this assay shall be able to assess the growth promotion capabilities of their culture medium, culture conditions and personnel skill through interlaboratory comparison by using the same cell culture (same cell type from the same source –donor- and with the same in vitro base doublings).
Participants must culture a cell suspension, following their routine procedure, at the same concentration and expanded during the same period of time. The information to be reported is the total recovered cells and the corresponding cell doublings.
*This programme is initially focused on adult Mesenchymal Stromal Cells (MSCs).