Essential manufacturing scale-up considerations for cell and gene therapies

Demand for cell and gene therapy treatments continues to outstrip supply, with only a small portion of eligible patients receiving cell and gene therapeutic treatment, such as CAR-T cell cancer therapy — in part, due to limited manufacturing capacity and high costs. Scaling up both manufacturing programs and processes of gene and gene-modified cell therapies in preparation for IND filing presents significant challenges, from transitioning through discovery and clinical phases to achieving GMP-compliant commercialization. Open systems, manual processes, and contamination risks often complicate the process, making early consideration of scalability essential to avoiding delays and costly adjustments. This infographic provides expert tips and key considerations for developing a scale-up or scale-out strategy in cell and gene therapy manufacturing, to bring these transformative therapies to more patients in need.