The Translation of Cell-Based Therapies: Clinical Landscape and Manufacturing Challenges

TLDR

Cell‑based therapies hold promise for unmet patient needs, yet their impact depends on effective manufacturing, which requires overcoming numerous challenges and clarifying production requirements. The study aims to inform industry and academia about current clinical development of cell‑based therapies and to identify gaps in their manufacturing requirements. The authors cataloged 1,342 active trials by cell type, indication, and phase, and evaluated multiple manufacturing technologies to support product translation and future process development.

Abstract

Cell-based therapies have the potential to make a large contribution toward currently unmet patient need and thus effective manufacture of these products is essential. Many challenges must be overcome before this can become a reality and a better definition of the manufacturing requirements for cell-based products must be obtained. The aim of this study is to inform industry and academia of current cell-based therapy clinical development and to identify gaps in their manufacturing requirements. A total of 1342 active cell-based therapy clinical trials have been identified and characterized based on cell type, target indication and trial phase. Multiple technologies have been assessed for the manufacture of these cell types in order to facilitate product translation and future process development.