Quality by Design Focus for Statistical Modelling
By Julia O'Neill and Ian Cox
In biopharmaceutical development, the importance of a methodical, risk-based approach to efficiently achieving desired product attributes cannot be overstated.
Quality by Design involves defining clear requirements and then striving to better understand how input materials and process conditions must be controlled or changed to deliver what’s required. As part of this approach, some companies integrate statistical modeling throughout the product lifecycle to better manage risk, and learn more quickly and reliably. Such companies often derive significant competitive advantage from this.
In this video, you will see firsthand how the integration of statistical modeling throughout biopharmaceutical development can achieve these results, leveraging designed experiments and observational data to create a coherent narrative. Additionally, the video will show real-world examples from pioneering biopharmaceutical cases to illustrate the accelerating power of statistical modeling in Quality by Design.