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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Research Article

The necessity of automated manufacture for cell-based immunotherapies: a cost-based analysis

Ryan McCoy, Jahid Hasan, Stephen Ward & Nicholas Gaddum

Automation adoption is a fundamental requirement to de-risk manufacturing processes and support sustainable commercial realization of cell and gene therapies. In this study, we examined cost and productivity sensitivities to increasing automation for the manufacture of cell-based immunotherapies. Firstly, we stratified automation adoption into four strategic levels (Manual, Bolt-together, Integrated and High-throughput) and adapted each to support the manufacture of an exemplar CAR-T immunotherapy. Then, using an internally developed modelling tool, we demonstrated automation adoption at the Bolt-together level reduced the Cost of Manufacture (23%) to Manual processing with limited further reductions seen as a function of increasing automation levels (max 30%). However, more significantly, we illustrated how automation adoption delivers increased throughputs (batches/yr) proportional to automation level in the example modelled, when maintaining facility footprint and constraints. This study highlights the value of employing modelling tools to strengthen early-stage development activities with respect to the assessment of automation adoption strategies to support commercial realization and confirms the requirement for automation if cell and gene therapies are going to realize their full potential at industrial scale.

DOI: 10.18609/cgti.2020.071
Citation: Cell & Gene Therapy Insights 2020; 6(5), 673–690
Open access
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