The Shift To GMP-Compliant Automation In Cell And Gene Therapy Manufacturing

Cell and gene therapies (CGTs) are moving rapidly from the lab into commercial manufacturing, but their complexity, the fragility of their living materials, and the need for aseptic production require a significant shift in manufacturing strategy. To minimize contamination risks and meet strict guidelines like Annex 1, the industry is increasingly adopting automated, closed systems.

Traditional “functionally closed systems” often rely on single-process equipment and fragile plastic containers, leading to bottlenecks and high costs. The next generation of true closed systems uses isolators with features like hydrogen peroxide vapor decontamination, positive pressure, and HEPA-filtered unidirectional airflow to maintain absolute sterility. These systems allow production in lower-grade cleanrooms, offering improved energy efficiency and lower facility costs.

For equipment manufacturers, this transition demands a ground-up design approach that incorporates every element—from hygienic fasteners to 21 CFR Part 11-compliant software—to ensure full compliance and streamlined validation. Discover how transitioning to fully automated, closed-system manufacturing is essential for scalable, reliable, and regulatory-ready commercial CGT production.