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.

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.

• 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.