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.
- Highlight the existing disparities in viral vector manufacturing processes compared to the established methodologies for monoclonal antibodies, emphasizing how this variability affects product quality and comparability across different therapies.
- Discuss how the lack of standardized platforms hampers effective scalability and complicates the assessment of therapeutic equivalence. This inconsistency makes it difficult to compare outcomes across different production methods and facilities.
- Explore potential strategies for developing standardized manufacturing processes that promote comparability, including regulatory considerations and collaborative efforts within the industry to enhance reproducibility, quality control, and benchmarking of viral vector therapies.
