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Opinion|Videos|January 19, 2024
Discovering the unknown: How does in silico process development change PD scientists’ work?
Author(s)Cytiva
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perform process development in silico? Do I need to be a math expert? Where is modeling applicable? Will I not set foot in the lab ever again?
Nora Ketterer, Manager of Modeling Services, Cytiva, explains how to perform in silico process development and comments on the application of mechanistic modeling.
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Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
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FDA’s rare disease framework effort will revisit evidence expectations and manufacturing review, with public input starting Oct. 28.
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