Advanced therapy medicinal products (ATMPs) face a distinct manufacturing challenge: delivering patient-specific therapies with reproducible quality, acceptable cost, and GMP-compliant manufacturing control. This narrative review examines how, over the past decade, the manufacturing of these therapies has moved from operator-dependent, open workflows toward more automated, closed or functionally closed, and increasingly data-supported process architectures. Three converging technology streams are discussed: (i) closed and semi-closed automated platforms for GMP-compliant cell manufacturing, (ii) advanced bioprinting and 3D manufacturing systems for tissue-engineered products, and (iii) digital twin concepts and related data-driven strategies as emerging enabling layers for monitoring, traceability, and process support. Across these domains, the dominant engineering trend is a shift from standalone equipment toward integrated frameworks aimed at reducing operator dependence, improving reproducibility, and strengthening GMP readiness. Overall, the field is shifting from isolated tools to more coordinated, automation-oriented, and increasingly data-supported workflows.
A decade of innovation in healthcare: Automation, bio-printing and digital twin technologies for personalized therapies
Ghavami, Donya;Giulietti, Nicola
;Sandri, Giuseppina;Giberti, Hermes
2026-01-01
Abstract
Advanced therapy medicinal products (ATMPs) face a distinct manufacturing challenge: delivering patient-specific therapies with reproducible quality, acceptable cost, and GMP-compliant manufacturing control. This narrative review examines how, over the past decade, the manufacturing of these therapies has moved from operator-dependent, open workflows toward more automated, closed or functionally closed, and increasingly data-supported process architectures. Three converging technology streams are discussed: (i) closed and semi-closed automated platforms for GMP-compliant cell manufacturing, (ii) advanced bioprinting and 3D manufacturing systems for tissue-engineered products, and (iii) digital twin concepts and related data-driven strategies as emerging enabling layers for monitoring, traceability, and process support. Across these domains, the dominant engineering trend is a shift from standalone equipment toward integrated frameworks aimed at reducing operator dependence, improving reproducibility, and strengthening GMP readiness. Overall, the field is shifting from isolated tools to more coordinated, automation-oriented, and increasingly data-supported workflows.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
