Development of serum-free, xeno-free medium for T cells therapeutic applications
2Davidoff Center, Rabin Medical Center, Petah Tikva, Israel
3Department of Clinical Microbiology and Immunology, Sackler School of Medicine, Tel Aviv University, Israel
Cell-based immunotherapy is at the forefront of advanced cancer treatments. To date, Chimeric Antigen Receptor T cells (CAR-T) and Tumor Infiltrating Lymphocytes (TIL) are the most prevalent cell-based immunotherapies.
Cell production for immunotherapy is usually performed with human serum as a supplement in culture media. While beneficial to cell growth, the use of serum introduces variability into the process, raises questions about treatment safety, burdens the regulatory issues and may have connection to inconsistent clinical outcomes.
4Cell® Nutri-T is a novel xeno-free medium formulation, developed for culturing of T-cells, without the need of serum supplementation. 4Cell® Nutri-T was developed using healthy and patient PBMCs, CAR-T cells and TIL. The use of patient`s cells during medium development is a unique approach with a great advantage towards clinical applications.
In the developmental screening phase, 4Cell® Nutri-T exhibited promising results in terms of cell growth, viability, and phenotype characteristics, for both healthy donors and patient-derived T cells.
Here we present the performance of 4Cell® Nutri-T medium that recently received GMP grade status. The 4Cell® Nutri-T has been tested for cell growth performance using a CAR BCMA clinical procedure, at the Ella Lemelbaum Institute, Sheba Medical Center. The 4Cell® Nutri-T showed comparable performance in all essential criteria to that of the commercial product, which was supplemented with 5% human serum. The 4Cell® Nutri-T medium has been approved for use in a CAR BCMA clinical protocol by the Ministry of Health and it has already been used in the clinic.