Efficient bioprocess characterization is essential for both regulatory compliance and commercial viability of biologics. Traditional approaches using resolution III/IV screening designs followed by response surface methodology are time-consuming, costly, and not always effective in identifying the important experimental effects. Definitive screening designs (DSDs) represent a novel class of three-level screening designs that can simultaneously evaluate main effects and quadratic relationships. While DSDs are increasingly used in bioprocess development, practical implementation guidelines remain limited. This case study bridges this gap by introducing a model-based framework to identify critical process parameters (CPPs) and optimize operating ranges for robust biologics production using plasmid DNA (pDNA). Minimal 14-run DSDs evaluated six input parameters and successfully identified CPPs and optimal operating ranges. This approach reduces experimental requirement by >50% compared to traditional designs, providing an efficient and economical strategy for bioprocess characterization and optimization.
Tag: <span>process characterization</span>
Process characterization using qualified scale-down models (SDM) offers time and resource-saving advantages to companies developing biotherapeutics. Current approaches with glass benchtop bioreactors as SDMs have demonstrated the ability to predict process performance and product quality, but are throughput- limited by infrastructure that requires significant operational input, as well as large volumes of media and reagents. In this article, the Sartorius Stedim Biotech ambr®250 high-throughput, single-use mini bioreactor system will be discussed for its suitability as an SDM for process characterization.