Manufacturing of Lots of Human T-Lymphocytes for Cell Therapy.

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]