Smart Scaled-Down Models

Cell & gene therapy processes are characterized by unparalleled costs and process complexities. Single-runs can cost tens of thousands of euros and take weeks to complete, while involving countless biochemical reactions of which a fraction is properly understood. This makes process development and characterization slow, expensive, and puts commercial viability at risk.

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Scaled-down process models are miniature versions of full-scale unit operations which can be run in parallel at a fraction of the cost. They enable the generation of a wealth of process data for process development and characterization. Crucially, they are recognized by regulatory authorities: 

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“A scale-down model is a representation of the proposed commercial process. Small-scale models can be developed and used to support process development studies. A scientifically justified model can enable a prediction of quality, and can be used to support the extrapolation of operating conditions across multiple scales and equipment.” - ICH Q11 

Smart Scaled-Down Models by Antleron 

Antleron combines medical 3D-printing capabilities and bioprocess engineering expertise to create bespoke scaled-down models tailored to your bioprocess. We leverage the scaled-down model’s potential by pairing it with a digital twin that contextualizes scaling effects, enabling data-driven insights and predictive modelling for full-scale development.