8:00 am Check-In & Coffee
9:00 am Workshop A
Navigating Regulatory Challenges in Viral Vector Process Development with Insights from Commercialized Products
Synopsis
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.
12:00 pm Lunch Break & Networking
1:00 pm Workshop B
Navigating the Challenges of Viral Vector Manufacturing: The Need for Standardization & Comparability
Synopsis
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.