ILANIT 2023

Development of advanced serum-free, GMP media for T cells towards Cell-based immunotherapy

Sharon Daniliuc 1 Marina Teverovsky 1 Adi Aisenshtat 1 Michal Besser 2 David Fiorentini 1 Mira Genser-Nir
1R&D Department, Biological Industries Sartorius, Israel
2Ella Lemelbaum Institute for Immuno Oncology, Sheba Medical Center, Israel

Human serum (HS) is the most traditionally prevalent supplement for the culture of T cells in research and clinical approaches. Moreover, the addition of HS is usually at relatively high concentrations (5-10%).

The use of serum introduces variability into the cell culture process, increases regulatory burden, and may lead to inconsistent clinical outcomes and to patients’ safety issues.

With the increasing regulatory requirements towards therapeutic applications, defined Serum-free medium for cells-based therapy approaches is required.

4Cell® Nutri-T media have been developed for the growth of PBMCs from healthy and patient donors (e.g., CAR-T and TIL) without the need for the addition of human serum.

In this poster we demonstrate the performance of 4Cell® Nutri-T XF GMP, using both healthy PBMCs and patients CAR-T cells, as well as preliminary results of Animal Components Free (ACF) defined medium, that is an advanced medium version from regulatory perspective. Results show that eliminating of HS does not compromise performance, including cells viability, proliferation rate and transduction efficiency.

Introducing advanced culture media, that do not require serum supplementation, will enable efficient and safer immunotherapy applications with fewer regulatory restrictions for their approval.