Future Supply Chains Enabled by Continuous Processing

In this section, we explore the potential new business models and value propositions that might emerge from a more integrated E2E continuous manufacturing-based supply chain and whether the existing infrastructure meets the needs of the changing product portfolio. Example developments to capture value across the supply chain include:

• Emergence of products supported by Medical Diagnostic Devices enable the capturing of product demand requirements directly between patient and drug provider.3 In a highly networked scenario, the supply chains would operate as reconfigurable and adaptive networks that are IT enabled responding to demand fluctuations, linked to remote Patient Diagnostic and Management Systems.
• Technology Convergence; between and within medical technologies that support new (more integrated and patient centric) product and product-service solutions that are more effectively delivered through multiple supply chain models including continuous processing-based supply.
• The potential development of personalized packs described earlier, through technologies that support late customization of products, and novel packaging solutions that facilitate patient compliance and adherence, such as multi-product personalized pack-solutions.
• Decentralized supply models; current batch practice to develop sophisticated scale-up scenarios often involves developing forgiving materials or reactions and as a last resort to widen the quality specs, and locking them as late in the development process as possible. Continuous processes however slice the process conditions along a time axis and hence allow much smaller distances between process conditions as enforced at the boundary of our controllable space and the entirety of the material. This leads to the need to not only know better about the process, but ability to control at a micro level with consequences for improved quality. The other consequence is that the equipment as such is never holding the entirety of material all at once and typically is not only from a reactor room perspective but also from a footprint perspective significantly smaller. Consequently, the process equipment is smaller, the development process is technically more complex but gives better understanding sooner in the process and hence opens the path to much more decentralized supplies for commercial supply scenarios (but also for late phase development scenarios where the supply aspects becomes inherently more important over the "create" aspects of R&D). Whereas for a classical batch regime, this typically involves a monolithic supply center, the continuous paradigm opens the opportunity of developing the fundamental process understanding earlier in R&D. The quantities of materials needed to develop a higher level of process understanding is reduced and then the scaling becomes much less of an issue, if there is a scaling needed at all. Procedurally speaking, the technical transfer into a continuous supply center can take place sooner in the technical development timeline, or if the responsibility is transferred by the regulatory status of the project ("R&D hands over to TechOps at Phase III supply manufacture") in other words, with fewer development efforts.
• Risk Transfer and Commercial scale-up; if the product volumes are significantly smaller as compared with a blockbuster scenario, then the phase III supply and the launch supply have a chance to be on the same process equipment and even a sustainable commercial supply can be organized in a significantly smaller decentralized supply scenario avoiding risky technical transfers. Risk reduction is plausible as the amount of process enforceability at a micro-level is significantly better giving fewer degrees of freedom for things to go wrong upon site transfers. It needs to be understood though that the technical (engineering) complexities of a continuous production are significantly higher in the design and operational phase.
• Reconfigurability of assets: although continuous process engineering and science will drive more complex processes, they will provide opportunities for better process control, better quality, and smaller footprints, leading to smaller supply centers and eventually faster transfers into them. Taken one step further, the localization of this value generation allows a much greater flexibility in terms of physical assets as a smaller plant is easier to relocate, and the driving factor becomes much more the availability of human brain-power at these dispersed locations to manage the inherent process complexities.

Existing infrastructure is unlikely to support the needs of the evolving portfolio and emerging supply models; fewer blockbusters, more niche products, stratified/personalized medicines. Nor is that infrastructure likely to be in the right place with changes to markets, products, and scale. With the emerging markets playing a bigger role in the future thought needs to be given to how they are effectively supported and how this might impact changing industry structure from both a geographical distribution perspective, and asset ownership with contract manufacturing models providing specialist capability and capacity. The potential of reduced inventories and work-inprogress represents perhaps the greatest opportunity for value creation with potential to take out up to 1 year of inventory across the extended supply chain.