Breaking The Doe Bottleneck: How Definitive Screening Designs Enable Faster, Cheaper Biologics Process Development

By Dogan Ornek, Nida Sayed, Jiangshan Zhou, Justin Lin, and Philip J. Ramsey

Optimizing biologics process development is critical for meeting regulatory requirements and achieving commercial success, yet traditional screening methods often prove costly and time-consuming. By utilizing a model-based framework driven by definitive screening designs, researchers can simultaneously evaluate main effects and quadratic relationships while reducing experimental requirements by over fifty percent.

This streamlined methodology cuts down the time and resources needed to characterize complex fermentation parameters for plasmid DNA production. Through advanced statistical modeling and targeted model selection strategies, teams can reliably identify critical process parameters, optimize operating ranges, and establish robust design spaces with fewer overall runs.

Explore the full resource to discover how implementing these advanced screening frameworks can accelerate your biomanufacturing workflows and enhance process reliability.