Future Supply Chains Enabled by Continuous Processing

Here, we consider the desirable future product, process, and supply network configuration models in a highly continuous manufacturing innovation and supply model. It is perhaps important to note that we envisage multiple supply chain models with configuration scenarios that include:

• Geographically dispersed production networks, supported by more repeatable continuous-based production processes, and offering significant volume flexibility with a flow-through demand driven supply dynamic, progressively replacing the "batch campaign". Unit operations will involve fewer production steps that change production dynamics from multi-stage multi-location to single location processing.
• Multiple supply chain models that support different levels of geographical reach, with, for example, centralized supply solutions feeding late customized/consolidation models; or alternatively dispersed supply models that support local near-market replenishment models.
• Fragmentation of the downstream supply chain with new "actors" emerging providing specialist services and operating within agreed operating models.
• Localization in small markets is enabled by small continuous lines; the "Factory in a box" is one scenario but so are smaller more standard factory operations that are substantially less capital, labor, and energy intensive providing more resource-efficient sustainable operations.
• Manufacturing "on-demand" with less inventory enabled by continuous lines, which are very well controlled at steady state - reducing the uncertainty of current manufacturing and forecasting processes.
• Continuous processes that enable closer coupling of API and Drug Product operations. However, the need for buffers of intermediate materials should not be wholly discounted. From a quality perspective, control of particles at API should enable more reproducible drug substance manufacture.
• Looking to the future, 3D printing-based supply models enabling local manufacture for a patient-specific drug as part of future developments in personalized medicine.

The transformations will require changes to the roles of existing industry players supporting these more patient-centric demand driven supply chains. From an equipment perspective, improved sensor and control systems to match up to a plug and play approach on a particular manufacturing site, potentially rolled out to across multiple locations. In this scenario, a number of small flexible factories controlled centrally in their operation may support Intellectual Property control and quality assurance while having geographically dispersed physical manufacture.