Automating decentralized manufacturing of cell and gene therapy products.

Decentralized, or redistributed manufacture, is likely to be the manufacturing approach of choice for some cell- and gene-based therapies, in particular, personalized therapies. Such an approach will ultimately depend on the business model and will take into account the regulatory and supply chain factors. Advances in technology and integration of automated production platforms have demonstrated the potential for decentralized manufacturing, however there is a need to extend the scope of automation across the entire process including the cell isolation, distribution, tracking, administration, quality management systems and development of automated analytical techniques to facilitate real-time release. For decentralized manufacture to be successfully integrated for cell and gene therapy production, lessons from other accepted healthcare-associated models of manufacture can provide useful insights and perspectives to make informed decisions. Such models share similar characteristics to decentralized manufacture in that they are patient-specific and have a limited time-frame for administration. These existing approaches, which have successfully incorporated aspects of automation, can provide a blueprint for success and may expedite the decentralization of patient-specific cell and gene therapy manufacture.