3D-printing in pharmaceutical drug manufacturing : unpacking the drivers and deterrents

Abstract

Introduction: Additive Manufacturing (AM), leveraging 3D printing technology, offers transformative potential for producing personalized medicines on-demand directly at the point-of-care (POC). The translation of AM into regulated clinical practice could be challenging. Key obstacles include fragmented regulatory frameworks, uncertain applicability of Good Manufacturing Practice (GMP) standards, and persistent knowledge gaps in risk and quality management within decentralized clinical settings.

Aims: ▫ To synthesize and critically evaluate principal challenges associated with implementing 3D printing for pharmaceutical drug products in decentralized settings (e.g., hospitals and community pharmacies). ▫ To examine emerging regulatory frameworks governing POC manufacturing and generate a comprehensive understanding of regulatory, technical and practical factors necessary for integration of AM into pharmaceutical practice.