Toward Quality by Design: Raw Materials Properties in Drug Product Development

This presentation provided an in-depth look at the evolving strategy implemented at UCB for integrating raw material properties into process development. The session began with an overview of the Quality by Design (QbD) workflow, emphasising the importance of defining the product and its quality attributes at the outset of development. Stauffer highlighted the need to characterise the link between critical process parameters, critical material attributes, and critical quality attributes to establish a robust control strategy. 

Stauffer discussed the limitations of traditional characterisation methods, which often focus solely on particle size distribution and flowability. She pointed out that these methods were insufficient for predicting granulation quality, as surface properties and other material attributes also played a significant role. This realisation led to the adoption of a more comprehensive approach, evaluating multivariate potential critical material attributes through systematic characterisation of new materials, including APIs and excipients. Collaboration with excipient manufacturers was deemed crucial for identifying sources of variation and understanding their impact on the process. 

The presentation also covered the iterative approach of particle engineering studies to explore and anticipate future variability. By designing particles with controlled variations, UCB aimed to extend their understanding of process robustness against different types of variability. Stauffer explained that this approach helped in designing a robust process that could withstand changes in raw material properties, thereby ensuring consistent product quality. 

Another key point was the use of machine learning to analyse large datasets generated during development. Stauffer described how machine learning applications could identify sources of variability that were not initially considered, leading to a deeper understanding of material attributes and their impact on the process. This data-driven approach allowed for continuous refinement of raw material variability estimation and supported robust process development and specification management throughout the product lifecycle. 

In conclusion, Stauffer's presentation underscored the importance of integrating raw material characterisation into process development. By leveraging advanced techniques such as particle engineering and machine learning, UCB aimed to ensure robust manufacturing processes and consistent product quality.