(492f) Assessing Statistical and Practical Significances during Small Scale Model Qualification for Biopharmaceutical Downstream Process

Small scale models are important in biopharmaceutical downstream process development, scale-up, technology transfer, process characterization, and process validation. Small scale models are usually justified by conducting small scale model qualification (SSMQ). During the qualification, product quality attributes and process performance attributes from a small scale model are compared statistically and practically with the attributes from the corresponding large scale system. While statistical methods are commonly used to evaluate equivalency between the scales, the assessment of practical equivalency can often be challenging. In this presentation, we will discuss the approach to evaluate statistical significance and focus on the practical significance evaluation during small scale model qualification.