Decentralized manufacture of cell therapies: the challenge of operational modeling

Cell & Gene Therapy Insights 2019; 5(10), 1133-1149.


Published: 23 October 2019
Expert Insight
Nicholas Medcalf

Cell therapies may often benefit from a decentralized manufacturing approach. In order to choose from amongst the possible options and to coordinate the activity of the various agents in the chain of value the industry needs reliable decision-making tools. Three tools are offered here that will help with evaluation of this route. Tools for enterprise modeling, inclusive cost analysis and timing of research investment are introduced, showing the potential for applying systems engineering to decentralized manufacturing. The case is made for initiatives to encourage communities of practice and data-sharing for operational models and unit operations.