Abstract

Ultra scale-down (USD) models have emerged as indispensable tools, addressing challenges in process development and optimization. This review delves into the transformative potential of Ultra Scale-Down (USD) models, exploring their applications, benefits, limitations, and future directions. As industries deal with more complicated manufacturing processes, the integration of USD models into development pipelines becomes crucial. This approach holds the potential to reduce timeframes, cut costs, and enhance the overall efficiency of various processes, contributing to advancements across diverse fields. Envision transforming intricate manufacturing not through colossal machinery but by harnessing the capabilities of tiny vials and microfluidic chips. This encapsulates the essence of ultra scale-down (USD), an innovative approach that downsizes the landscape of process development. Essentially, USD duplicates pivotal elements of large-scale processes on a considerably smaller scale, typically employing milliliter-sized volumes. While USD is still advancing, and its potential to transform process development is evident. Embracing miniaturization, researchers and engineers unleash efficiency, cut costs, and hasten the launch of innovative products. Keywords: Ultra Scale-Down (USD) models, Downstream processing, Cell-based therapies, Early-stage optimization, Real-time applications, Personalized medicine

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