From Bench to Bedside: Mastering QC & CMC Alignment to Meet Evolving Regulatory Standards
Time: 1:00 pm
day: Pre-Conference QC Readiness Track B - PM
Details:
Ensuring QC readiness and CMC alignment is critical to the successful development and regulatory approval of gene therapies. As regulatory standards evolve, especially with the complexities of viral vector production, maintaining consistency and meeting compliance requirements at each stage—from early development to clinical trials-is essential.
- Timing & Implementation of QC Assays: Identifying the optimal stages to introduce specific QC assays that align with development milestones and meet evolving regulatory requirements, ensuring both timely and compliant assessment
- Addressing Evolving Regulatory Standards & CMC Alignment: Discussing the integration of ICH Q14, FDA, and EMA guidance into the CMC strategy, with a focus on maintaining QC readiness throughout the development phases, particularly during late-stage development and clinical trials
- Ensuring Consistency & Robustness of Viral Vectors: Tackling challenges in viral vector production, ensuring batch-tobatch consistency, and developing fit-for-purpose analytical methods for potency assays, while meeting both global and European
