Manufacturing Chemist: How early data drives better cell line development

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.

Meticulous records of clonality, phenotypic stability and quality control do more than simply satisfy regulators.

They set an established groundwork for reproducible yield and effective tech transfer from early stage development to large-scale manufacture.

When early data points are justified, scientifically defendable and transparent, everyone wins.

“Robust early data lays the groundwork for reliable biologics manufacturing,” says Brett Verstak, PhD, Head of Cell Line Development at Abzena.

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