Conclusions

In this discussion and review piece of industrial and academic perspectives on the future supply chain models that might be underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out:

  • The significant opportunities to moving to a continuous manufacturing supply chain operating model, with substantial opportunities in inventory reduction, lead-time to patient, within radically different product assurance/stability regimes.
  • Scenarios for significant decentralized production and supply models producing a greater variety of differentiated products with greater volume flexibility and opportunities for rapid scale-up post clinical trials.
  • Production, supply, and value chain footprints that are radically different from today's monolithic and centralized batch manufacturing operations.
  • Clinical trial and drug product development cost savings that support more rapid scale-up and market entry models, with early involvement of SC designers within New Product Development.
  • The major supply chain and industrial transformational challenges that need to be addressed.

Although the potential benefits against current batch performance benchmarks are significant, identifying the product supply chains where benefits might be most attainable is complex and the transformation journey far from straightforward, with future archetypes including hybrid batch-continuous scenarios.

Benchmark studies should also consider improvements to current batch operations which operate far from optimal levels. Indeed, some industry observers will question whether the pharma sector can effectively implement these more technically complex continuous processing supply models models that require production to operate at near optimal levels "by-design," or whether this very requirement will in itself help drive the efficiency improvements demanded by patients and payers alike.