Cell And Gene Therapy: A Driving Force For Advanced Cleanroom Standards

Designing cleanrooms for Advanced Therapy Medicinal Products (ATMPs) is complicated by conflicts between GMP contamination control and BSL biocontainment guidelines. Driven by the expanding ATMP market and complex therapies requiring multimodal facilities, these conflicts necessitate innovative approaches. Regulatory frameworks from ISO 14644, FDA/EU GMP, and WHO/CDC/NIH biocontainment standards create a complex landscape.

A central conflict arises from the opposing airflow directions: outward cascade for cleanrooms versus inward cascade for BSL labs. Compromise solutions, such as “sink” anterooms, while partially resolving issues, increase design complexity and costs. The adoption of single-use systems and modular cleanrooms further challenges traditional approaches. Collaboration among engineers, regulators, and researchers is essential to simplify designs, foster innovation, and ensure safety.

Read this article to discover these critical regulatory design conflicts and explore innovative solutions for ATMP facilities.