Based on the written documents, a GMP-compliant manufacturing process in a clean room environment is executed. One vial from a defined pre-cell bank is thawed and the cells are revitalized. For about ten to eleven days, the cells are grown in Erlenmeyer flasks in a shaker incubator until the necessary cell count has been reached. Finally, a freezing suspension -containing cells, culture medium, and DMSO as cryo protectant - is mixed and aliquoted into vials. Our trained and experienced staff ensure a homogeneous distribution of the cell suspension across all vials. While the vials are frozen to -80°C, the temperature is recorded. At the end, the vials are transferred into liquid nitrogen tanks for safe long-term storage. All manufacturing steps as well as results of in-process analytics are summarized in a batch record.
