The term blockchain is most often associated with cryptocurrencies such as Bitcoin, but the technology and its implications could have a more far-reaching impact on other industries including pharmaceutical manufacturing. Contract drug manufacturing organizations (CDMOs) and pharmaceutical developers could realize tangible benefits by implementing a variant of blockchain termed “Distributed Ledger Technology” (DLT). DLT promises to provide better transparency within the pharmaceutical supply chain, create cohesive hand-offs, increase traceability, and prevent fraud or counterfeiting. There are several ways to implement DLT within a pharma supply chain, including FDA mandate or guidance, leadership from a pharmaceutical company or consortium, or ecosystems that self-organize. Major challenges in executing a DLT include platform integrations, cost, governance, and accountability. To explore theoretical DLT applications, we illustrate using the drug product manufacturing fill and finish CDMO ecosystem of Argonaut Manufacturing Services.
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