Blockchain technology for advanced therapy medicinal products: Applications in tracking, data sharing, and supply chain automation

Abstract

Advanced therapy medicinal products (ATMPs) like cell and gene therapies offer transformative treatment options for many diseases. However, coordinating the decentralized, patient-specific manufacturing of autologous ATMPs across multiple hospitals poses major supply chain challenges. This paper provides a comprehensive analysis of how blockchain technology can enhance decentralized ATMP manufacturing networks. First, background on ATMPs and complexities of decentralized production is reviewed. An overview of blockchain architecture, key attributes, and existing use cases then follows. The major opportunities for blockchain integration in ATMP manufacturing are discussed in depth, including tracking autologous products across locations, enabling data sharing between hospitals to power AI-based optimization, automating supply chain processes, and maintaining provenance records. Critical limitations around scalability, privacy, regulation, and adoption barriers are examined. Design considerations for developing blockchain ecosystems tailored to the unique ATMP environment are also explored. Blockchain shows immense promise for transforming visibility, coordination, automation, and data unification in decentralized ATMP manufacturing networks. Despite current challenges, blockchain is prepared to profoundly impact the advancement of personalized cell and gene therapies through enhanced supply chain instrumentation. This paper provides a comprehensive analysis of this emerging technological innovation and its applications to address critical needs in ATMP translation and manufacturing.