Cell Therapy: Getting GMP Right

Researchers from the Fred Hutchinson Cancer Center and Seidman Cancer Center have outlined foundational steps and quality considerations for establishing and maintaining GMP cell processing programs in academic and early-phase settings. The framework draws from international regulatory standards set by agencies such as the FDA, EMA, and ISO, and covers several areas, such as facility management, personnel, equipment management, supplier management, audits, among others.

At the early stages of development, some scientists choose not to worry about GMP, but the authors stress that getting a facility and processes right, early on, is imperative. “For many academic centers, budget, available space and access to required infrastructure become limiting factors in the ability to design and maintain the appropriate GMP-compliant environment for complex cell processing. Even for manufacturing in early-phase studies, thoughtful attention to facility design quality is integral to maintaining a controlled environment that ensures product quality and personnel safety,” the authors write.

Facility design and environmental control are highlighted as core elements of GMP compliance. The paper outlines infrastructure and quality metrics required for cleanroom environments, utility systems, and equipment maintenance. It also underscores the importance of integrating biosafety procedures, pest control policies, and validated sanitization protocols into standard operations.

Personnel management is another pillar of the framework. The authors write, “Even with increasing automation and closed system technologies in cell manufacturing, the recruitment, training and maintenance of competence of a highly skilled workforce remains critical to ensuring high quality output from cell manufacturing programs.

Their recommendations include implementing structured training programs to ensure staff are adequately prepared for their roles. Training should be tailored to specific job functions, with regular competency assessments and documentation to demonstrate compliance. Annual retraining and continuing education are emphasized as necessary to maintain workforce readiness, particularly in smaller academic programs where personnel may carry out multiple functions.

The framework also provides guidance on equipment qualification, which includes installation, operational, and performance verification. Equipment should be appropriate for its intended use, and maintenance and calibration schedules must be clearly defined. The authors recommend keeping detailed records of use, cleaning, and servicing to ensure traceability and support compliance reviews.

Overall, the authors argue that by embedding quality and GMP principles from the outset, even resource-constrained institutions can build manufacturing programs capable of supporting early-phase trials and scaling toward commercialization. While tailored to academic centers, the framework offers a broad reference for anyone developing cell therapy products in compliance with global standards.