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Kim G, Lin J, Valentino M, Colon-Gonzalez F, Waldman S
Berger, Z
2025;16(1):e13677
The design ensured: Cleanability and drainability across all piping Full instrumentation and automation ready for recipe management and process repeatability Efficient flow between buffer preparation, purification and intermediate storage Optimised footprint and ergonomics to fit the clients facility constraints A complete set of qualification protocols including FAT, SAT, IQ and OQ This integrated approach ensured process reliability, reduced installation risks and accelerated the clients readiness for commercial manufacturing
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