PPharmaceutics3/28/2026

A Novel Hypothermic Preservation Formulation Containing SUL-138 Enables Long-Term Hypothermic Storage of Clinical-Grade CAR-T Cells

Background/Objectives: Point-of-care (PoC) manufactured fresh chimeric antigen receptor (CAR)-T cells are typically formulated in hypothermic preservation formulations (HPFs) and stored under hypothermic conditions (2–8 °C) until administered to the patient. However, in current HPFs the shelf life of fresh CAR-T cells is short (~24–36 h) due to limited CAR-T cell stability, which poses significant time constraints on manufacturing procedures and logistics. The objective of this study was to impr