Considerations For AVV Analytical Comparability Studies For Products With Low Batch Numbers

By Sonya M. Schermann, Philipp Beck, and Markus Hoerer

This poster addresses critical considerations in conducting analytical comparability studies for Adeno-Associated Virus (AAV) products, specifically focusing on scenarios with limited batch numbers. Establishing comparability is a cornerstone of biotherapeutic development, ensuring consistent product quality, safety, and efficacy across manufacturing changes or process optimizations. However, low batch numbers introduce unique challenges, such as statistical limitations, reduced data robustness, and potential variability in analytical outcomes.

The study highlights strategic approaches to overcoming these challenges, including the selection of orthogonal analytical methods, optimizing assay sensitivity, and leveraging advanced statistical models to compensate for smaller datasets. Case studies demonstrate the application of these methodologies in real-world scenarios, offering practical insights into best practices for achieving regulatory compliance and maintaining product integrity.

For an in-depth exploration of these findings, including specific strategies and tools to enhance analytical comparability in low-batch scenarios, download the full poster to access the detailed data and recommendations.