Linking Pharma Manufacturing: CDMOs, Blockchain And Distributed Ledger Technologies (DLT)

By Wayne Woodard, Jeremy Macedo, and James Gilmore

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.