The crucial role of raw material selection for success in cell therapy manufacturing
Abstract: Cell therapy manufacturing is advancing rapidly, offering new therapeutic options for challenging diseases, but the complexity of production makes raw material selection a critical determinant of success. The quality, consistency, and traceability of raw materials—including cell culture media, cytokines, substrates, and disposables—directly impact product safety and efficacy. Transitioning from research-use to GMP-grade materials introduces regulatory and operational hurdles, while inadequate risk management can delay development and increase costs. A robust qualification framework and partnership with experienced CDMOs are essential to mitigate risk, ensure compliance, and accelerate patient access to life-saving cell therapies.