LAUSR

Background & Aim Cell therapy is a blossoming field that focuses on the application of cells as therapeutic products; accordingly, the associated manufacturing process is cell culture. The difficulty of generating sufficient cell numbers with consistent clinical quality, a major challenge in the field, can be mitigated by addressing two factors: cell source and media composition. The removal of undefined media components is essential for a dependable, reproducible manufacturing process and safe translation for clinical use. Therefore, the development of cGMP-manufactured T-cell culture media that can be used reliably to culture, differentiate, and expand T-cells under serum-free conditions is essential. Methods, Results & Conclusion Following FUJIFILM's rational design approach to media development, our extensive expertise has led to the creation of a chemically defined, animal-component free T-cell culture medium (CDM), with equal or better performance than other commercially available offers while being cGMP grade. Drawing from a vast registry of donors at HemaCare, we targeted peripheral blood mononuclear cells (PBMCs), positively selected CD3+ cells, and negatively isolated CD3+ cells, demonstrating the effectiveness of FUJIFILM Irvine Scientific's PRIME-XV T-cell CDM using multiple cell culture systems and activation methods. HemaCare's precisely isolated and purified cells cultured in PRIME-XV T-cell CDM maintained robust expansion, viability, and phenotype trends across donors and cell culture systems, from small-scale plates and flasks to scaled-up bioreactors.