Navigating Regulatory Challenges in Viral Vector Process Development with Insights from Commercialized Products
Time: 9:30 am
day: Pre-Conference Workshop Day
Details:
As viral vector-based therapies move from development to commercialization, regulatory challenges become increasingly critical. This session will focus on overcoming key regulatory hurdles in viral vector process development and manufacturing, including maintaining product consistency, standardizing assays, and ensuring safety across large-scale operations. This workshop will provide practical strategies and insights on achieving regulatory compliance while maintaining highquality standards in viral vector production.
1. Product Consistency & Comparability
- Techniques for ensuring batch-to-batch consistency during scale-up without compromising on quality, safety, or efficacy.
2. Standardization of Assays & Analytical Methods
- How to develop and validate robust analytical methods that meet regulatory standards and allow for reliable characterization of viral vectors.
3. Mitigating Risks Related to Immunogenicity & Capsid Ratios
- Best practices for addressing regulatory concerns surrounding immunogenicity, ensuring an optimal empty-to-full capsid ratio, and managing potential safety risks.
