Learning from the future: towards continuous manufacturing of nanomaterials

Abstract

Abstract The rise of continuous manufacturing (CM) in the pharmaceutical industry – particularly for the solid oral dosage form—marks a major shift in how drugs are made. Over the past decade, the adoption of CM has been fueled by notable reductions in operation costs and shorter regulatory approval timelines, setting the stage for applying CM to a wide range of drug products. Nanomaterial-containing drug products, typically liquid injectables composed of vesicles, particles, or globules, are strong candidates for future CM applications. The convergence of manufacturing technology with nanotechnology is already in progress; the rapid development and commercialization of lipid nanoparticle-based mRNA products during the pandemic exemplifies this synergy. While this success highlights the potential for rapid translation of scientific advancement into life-saving drugs, it also reveals limitations in our current capacity to scale production quickly and adapt to new therapeutic modalities. This situation underscores the urgent need for improvements in agile manufacturing technologies. Moreover, more frequent drug shortages, often stemming from quality issues and limitations in scaling up manufacturing processes, underscore the need for enhanced manufacturing capabilities to better respond to fluctuating market demand and patient needs. In this context, we will summarize some of emerging CM technologies for nanomaterials, explore the underlying principles, and discuss the untapped potential for modeling and simulation to inform the design and implementation of CM. Graphic Abstract

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