Analytics and Characterization Throughout the Manufacturing Cycle

Chair

Nathalie Clement, Vice President, Vector Development, Translational Gene Therapies, Siren Biotechnology

4pm Presentation Title: Overcoming Barriers With The Current State Of Analytics

• Strategic planning for phase appropriate evolution of analytics.
• Introduction of automation to enable increased throughput and assay precision

Sharmilee Patel, Head of Business Development, US EC, Senior Director, Oxford Biomedica

4.15pm Presentation Title: Analytical Considerations in the Gene and Cell Therapy Space

• Function of Analytical Development from Clinical to Commercial
• Complexities of Analytical Development in the Cell and Gene Therapy Space
• A Specific Example of a Modality Where Developing Robust Analytical Tools Can Influence Forward Progress in the Clinic

Francesca Vitalli, Vice President, Cell Therapy and Viral Vector Process Development, Intellia Therapeutics

4.30pm Presentation: In Silico Insights: Navigating the Road from Preclinical Promises to Clinical Success in Characterizing AAV-Based Therapies for Safety & Efficacy.

• Preclinical development of AAV-based therapies provides crucial insights into safety and efficacy, particularly concerning manufacturing impurities such as empty capsids or encapsidated non-therapeutic DNA.
• Drug developers can effectively characterize these manufacturing impurities early in preclinical development to address safety concerns
• Critical Quality Attributes (CQAs), specifically virus titer and content ratio, are essential for meeting regulatory requirements for efficacy and safety.
• This talk will uncover the methods used to measure CQAs and explore how in silico techniques are breaking bottlenecks and avoiding costly trial-and-error experimentation.

Mark Swendsen, Chief Revenue Officer, Form Bio

4.45pm Q&A