Theranostic nanomedicines are a promising new technological advancement toward personalized medicine.\nAlthough much progress has been made in pre-clinical studies, their clinical utilization is still under development.\nA key ingredient for successful theranostic clinical translation is pharmaceutical process design for production on\na sufficient scale for clinical testing. In this study, we report, for the first time, a successful scale-up of a model\ntheranostic nanoemulsion. Celecoxib-loaded near-infrared-labeled perfluorocarbon nanoemulsion was produced\non three levels of scale (small at 54 mL, medium at 270 mL, and large at 1,000mL) using microfluidization.\nThe average size and polydispersity were not affected by the equipment used or production scale. The overall\nnanoemulsion stability was maintained for 90 days upon storage and was not impacted by nanoemulsion production\nscale or composition. Cell-based evaluations show comparable results for all nanoemulsions with no significant\nimpact of nanoemulsion scale on cell toxicity and their pharmacological effects. This report serves as the\nfirst example of a successful scale-up of a theranostic nanoemulsion and a model for future studies on theranostic\nnanomedicine production and development.
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