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Oxygen control in static cell cultures is one of the most critical parameters of a process, influencing the metabolism of the cells and ultimately the final yield of the product. With the aim to improve the cultures of different types of cells, both anchorage dependent and suspension, we have carried out several experiments evaluating the behaviour of some types of cells, (CHO, CaCo2, hybridomas) in a new version of Cell Factory bioreactors (with gas and with gas + motion). The type of culture was the batch mode and the parameters checked were: 1. Time to attach to the surface, 2. Time to arrive to confluence, 3. Cells number at confluence, 4.Viability, 5. Glucose consumption, 6. Lactate production, 7. Product yield after purification. The results demonstrate that the gas blown into the bioreactor is beneficial for the cells in terms of time to reach confluence, cell growth and productivity, while the motion does not increase significantly the production and cell growth compared with static conditions. Other experiments are in progress to confirm these encouraging data by evaluation of gas mixing both in 10 and in 40 trays modules. [ABSTRACT FROM AUTHOR]

About 10 years ago nobody would have believed that cell therapy would become one of the future promises of therapy, and human cells one of the hopes for the cure of emerging diseases not treatable with conventional drugs. The advent and potentiality of stem cells and other types of cells as drugs is revolutionizing the production and regulatory fields. Producer and regulators alike have to be prepared to face with this new concept of therapeutics in terms of cell expansion related to the lot definition, bioreactor used, safety and QC tests for lot release. Here we describe a new process for the GMP manufacturing of human T lymphocytes not HLA restricted, for Phase I and Phase II clinical trials of different types of tumors. The process is based on the use of the modular and disposable bioreactor Cell Factory and was conceived to maximize the potentiality of the bioreactor related to the physiology of the cells. All the steps of the process from MCB thawing to the bags filling are discussed. [ABSTRACT FROM AUTHOR]