Why it’s critical to close open steps in cell therapy manufacturing
Abstract: Open steps in cell therapy manufacturing expose products to contamination risk, operational complexity, and scalability limitations. Regulatory guidance increasingly favors closed, sterile, and automated systems to enhance sterility assurance, inspection readiness, and cost efficiency. This article explains the practical differences between open and closed systems, the regulatory and operational benefits of closure, and provides a stepwise guide for closing processes. It underscores how early adoption of closed systems improves patient safety, scalability, and commercial success.