Scaling the Manufacturing Process: The Importance of Small Scale Models in Supporting Comparability Assessments
Time: 8:45 am
day: Day Two
- Animal models provide a critical framework for the preclinical evaluation of gene therapy products.
- The vectors generated for these nonclinical studies are typically made at a lab scale using a process that differs from the eventual clinical and commercial manufacturing processes.
- Often, these lab processes utilize techniques that are not scalable, resulting in impurity profiles that can drive differences in critical attributes and clinical performance of products – including in immune response, dosing, and toxicity. Ideally, manufacturing processes should be scaled with representative material, to support accurate product analysis and characterization through each phase of development.
- This presentation will discuss methods for comparability assessments to support translation and scaling of production processes.