Leveraging Advanced QbD Analytics to Define CQAs & Improve Plasmid DNA Process Robustness
- Define and control critical quality attributes (CQAs) for plasmid DNA, ensuring consistency, potency, and purity throughout development and scale-up
- Strengthen in-process controls and release testing frameworks to better link analytical outcomes with product performance and regulatory expectations
- Leverage advanced analytical tools for in-depth characterization, enabling greater process understanding, comparability, and data-driven decision-making