Navigating the Challenges of Viral Vector Manufacturing: The Need for Standardization & Comparability
Time: 2:00 pm
day: Pre-Conference Workshop Day
Details:
This workshop will explore the disparities between viral vector manufacturing and monoclonal antibody production, focusing on how variability impacts product quality, comparability, and scalability. We’ll discuss the challenges of lacking standardized platforms and the difficulty of ensuring therapeutic equivalence across different production methods. Strategies for standardizing processes, improving reproducibility, and enhancing quality control will be explored, alongside regulatory considerations and industry collaboration to improve viral vector production for gene therapies.
- Evaluate existing and emerging platforms for viral vector manufacturing, highlighting their advantages and limitations. Emphasize how platform variability impacts product quality and comparability across different therapies.
- Analyze various process and manufacturing changes throughout the drug development lifecycle. Provide a risk assessment framework to evaluate change impact and guide analytical comparability strategies.
- Explore potential approaches for establishing standardized analytical comparability, considering regulatory requirements and industry collaborations to enhance reproducibility, quality control, and benchmarking of viral vector therapies.