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Clinically Relevant Downstream Process Optimization
Introduction
In this success story, learn how Phosphorex helped an innovator optimize and scale a challenging downstream process for a novel LNP system. By combining process development expertise with a deep understanding of LNP critical quality attributes, our team helped establish a manufacturing-ready solution designed to support continued program advancement.
"This project came down to time and material. Our partner had a limited supply of RNA, so we couldn't afford a process that wasted product, and we were on a tight timeline. Moving from dialysis and Amicon-based processing to a TFF approach, then optimizing it with our scale-up methodology, cut processing time by more than half while keeping yield above 90%. The formulation reached its target concentration after the addition of sucrose and retained the quality attributes that mattered for the studies. That gave our partner the data they needed to make decisions about the next phase of their program.”
Matthew Freeman, PhD
Senior Scientist