| USING ADVANCED IMAGE ANALYSIS AND 3D
MODELLING TO ENSURE THE QUALITY AND SAFETY
OF GENE THERAPEUTICS IN AN ISOLATED
ENVIRONMENT
Nikola Cudráková, Petr Strakoš, Petra Svobodová, Milan Jaroš, Jaroslav Krutil, Ondřej Zbranek, Petr Lesný |
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| ABSTRACT: Maintaining consistent quality in pharmaceutical manufacturing is especially challenging in the manual production of gene therapeutics, where operator interactions within isolator environments play a crucial role. Traditional methods rely on manual documentation or basic video monitoring using single or multi-camera setups. Such approaches are limited in accuracy and scalability. This study proposes a novel framework that replaces conventional image analysis with advanced computer vision and real-time 3D modeling. By reconstructing operator actions in three dimensions, the system offers enhanced spatial precision and a richer interpretation of quality-relevant parameters. Více This capability enables more accurate monitoring of critical tasks, supports traceability, and strengthens process integrity. Through selected use cases, we demonstrate how this approach can improve the reliability of operator tracking and introduce new possibilities for quality assurance and auditing in the production of gene therapies. The results highlight the transformative potential of 3D computer vision technologies in regulated pharmaceutical environments. Keywords: gene therapeutics, isolated environment, advanced image analysis, 3D modeling DOI: 10.35191/medsoft_2025_1_37_cudrakova |

















