| Sumario: | The article focuses on advancements and challenges in downstream purification within biologics manufacturing, emphasizing how increased upstream productivity has outpaced downstream capacity, creating bottlenecks that affect timelines, costs, and commercial potential. It highlights the need for process intensification, flexible system design, and integration of real-time analytics—such as Raman-based process analytical technology (PAT) combined with artificial intelligence (AI) and machine learning (ML)—to improve throughput, scalability, and product quality. The article also discusses sustainability improvements through reduced buffer and water usage, the importance of regulatory compliance, and the role of industry collaboration in accelerating innovation and adoption of new technologies. Future downstream strategies are expected to prioritize modularity, flexibility, and incremental improvements to accommodate diverse therapeutic modalities and evolving manufacturing demands.
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