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In an industry where complex molecules and first-in-human (FIH) formulations often come with very limited API supply, material-sparing strategies are central to efficient CMC development. read more

In the race to bring new biologics to market, development teams are constantly balancing speed, quality, and regulatory expectations. Yet one factor often determines long-term success more than any other: the strength of the data generated in the earliest phases of cell line development. read more