A Living Comparability Protocol for Biopharmaceutical Manufacturing Processes That Continuously Evolve without Losing Product Understanding across Product Lifecycles
Marco De Luca, Giulia Ferraro, Antonio Russo, Elena Rossi
University of Naples Federico II University of Bologna University of Florence
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摘要与影响
Biopharmaceutical manufacturing processes evolve through scale changes, equipment replacement, raw-material variation, site transfers, analytical modernization, process intensification, and post-approval optimization. Conventional comparability plans are commonly structured around a defined change and a prespecified evidence package, but repeated and interacting changes can fragment product knowledge across development and commercial lifecycles. This article proposes a living comparability proto
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