Designing Early Manufacturing For Long-Term Success In CGT

Developers of cell and gene therapies face the dual challenge of moving quickly in early-phase clinical trials while planning for the rigor and scale of late-phase and commercial manufacturing. Early manufacturing decisions, ranging from cell processing and media development to analytics and expansion technologies, can have lasting consequences for scalability, compliance, and patient access. At the same time, processes must remain flexible enough to accommodate evolving clinical insights while robust enough to align with GMP expectations and eventual tech transfer. In this Cell & Gene Live, Cell & Gene's Chief Editor, Erin Harris, Raymond Luke, Senior Director, MSAT at Verismo Therapeutics and Todd Luman, Executive Director, Process Sciences at Allogene discussed best practices for designing adaptable processes, building a strong data foundation, and leveraging innovations such as automation and advanced analytics to prepare for long-term success.