performed preliminary study in which CIKs were expanded in RPMI + 10% Fetal Bovine Serum (FBS) to evaluate their effectiveness for antitumor activity against autologous bone sarcomas. They can be classically expanded starting from peripheral blood mononuclear cells (PBMCs) but may also be generated from bone marrow (BM) or umbilical cord blood precursors.
The clinical translation of adoptive immunotherapy with CIK cells as treatment for patients with solid tumors is currently the object of clinical trials and their number has increased in recent years. In conclusion, these preclinical validation data lay the bases for a GMP-compliant process to improve the CIKs expansion method.Ĭytokine-induced killer (CIK) cells are a very promising cell population which raise growing interest in the field of cellular antitumor therapy mainly due to their easy expansion method. We performed a validation consisting in three run-sand even if the small number of experiments didn’t permit us to obtained statistical results we demonstrated that both X-VIVO 15 and Tex Macs fulfilled the quality standards in terms of cellular growth, viability and identity while Cell Genix GMP SCGM resulted not compliant as it caused some technical problems such as high mortality.
TEXMACS MILTENYI FREE
Consequently, we decided to test three different serum free expansion media: X-VIVO 15, (largely used by other groups) and Tex Macs and Cell Genix GMP SCGM: two GMP manufactured media. Firstly, Human Serum (HS) and Human Pool Plasma (HPP) were tested as medium supplements giving not compliant results to acceptance criteria, established for CIKs, probably for the great batch to batch variability. We decided to replace Fetal Bovine Serum (FBS), largely used as medium supplement for CIKs expansion, with other culture media. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents. GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to good manufacturing practices (GMP). Cytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy.
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