Navigating Late-Stage Changes in Analytical Development to Ensure Regulatory Compliance & Mitigate Risks
Time: 1:20 pm
day: Day Two
Details:
- Explore the technical and regulatory hurdles faced when making changes to gene therapy products at late development stages, including changes to the viral vector, formulation, or assay systems, and how these can affect product consistency and regulatory compliance
- Discuss strategies for assessing and mitigating risks when making late-stage changes, particularly regarding how those changes might impact the quality, potency, or stability of the gene therapy product
- Review the regulatory landscape surrounding late-stage modifications, including the necessity of re-submissions, updates to the manufacturing process, or additional stability data to align with agency requirements
