Advancing 3D printing for personalized pediatric medicines: quality, safety, and Good Manufacturing Practice compliance

Abstract

Three-dimensional (3D) printing is a transformative technology that enables dose individualization in pediatric medicine and advances precision medicine. This facilitates the production of personalized drug formulations with variable dosages, sizes, and release profiles, thereby overcoming the limitations of conventional manufacturing. However, ensuring safety and efficacy requires optimization of critical quality attributes, robust analytical methods, and compliance with good manufacturing practices (GMPs). The PolyPrint consortium is developing innovative polymers and a GMP-compliant fused deposition modeling (FDM) 3D printer. This review covers the formulation strategies, quality considerations, and process validation of 3D-printed pediatric medicines, emphasizing regulatory compliance, printability, and engineering approaches for quality assurance in pharmaceutical applications.