Closed-system process optimization for CGT manufacturing and storage

Cell & Gene Therapy Insights 2025; 11(11), 1357–1362

DOI: 10.18609/cgti.2025.158

Published: 15 December
Innovator Insight
Erik Woods, Jon Pileggi, Sean Werner

The manufacture of cell and gene therapies (CGTs) faces persistent cost, quality, and contamination challenges from open, manual processing and uncontrolled storage. Transitioning to closed-system manufacturing and cryostorage has been shown to reduce batch failures threefold and manufacturing costs by up to 45%, while tripling throughput and maintaining cell viability. This article summarizes comparative data and case studies demonstrating how process closure supports scalable, contamination-resistant, and economically viable CGT production.

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