The use of isolators in cell, gene, and tissue therapy manufacturing is increasing due to their support of sterility assurance through effective microbial contamination control. However, many advanced therapy medicinal products (ATMPs) are sensitive to vaporized hydrogen peroxide (VHP), the standard agent used in isolator decontamination. This presents a challenge when transitioning from biosafety cabinets to closed-barrier isolator systems.This poster provides practical solutions to support the integration of isolator technology into ATMP manufacturing while addressing limitations associated with VHP-sensitive materials. Drawing from industry-based experience and collaborative practices, the poster outlines approaches to minimize VHP exposure risks while maintaining contamination control.Topics include isolator design, material selection and placement, process adaptations, and handling strategies for materials both time-sensitive and VHP-sensitive. Operational tips, including techniques to streamline material transfer and reduce open exposure time, are also shared.By offering actionable insights and lessons learned, this presentation aims to help process leads and microbiology professionals better understand how to successfully adopt isolators for ATMP processing. These strategies contribute to building robust, contamination-controlled environments that protect product quality while meeting time-sensitive sterility assurance goals in advanced therapy manufacturing.
Zoe Reilly (Thu,) studied this question.