8:00 am Check-In & Coffee
8:50 am Chair’s Opening Remarks
9:00 am Industry Leader’s Panel: Overcoming Profitability, Analytical Challenges, Emerging Technologies, & Future Directions
9:45 am Session Reserved for BioRad
10:15 am Presentation & Roundtable Discussion: A Review of Gene Therapy Release Assays & Their Utility
10:45 am Morning Break & Speed Networking
Synopsis
As this community re-unites for the 7th time, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections
Bioassays & Molecular Biology
Enhancing Potency Assessment in Gene Therapy for Reliable Assays & Regulatory Success
Overcoming the Challenges of NGS Validation for Gene Therapy Potency & Stability to Improve Consistency
12:15 pm Optimizing Potency Assays for Gene Therapy From Particle Correlation to QC-Friendly Methods
12:45 pm Develop New Assays in Days, Not Months: Get Low-variability Titer, VCN, and Genome Integrity without Tradeoffs
12:55 pm Lunch Break & Networking
1:55 pm Defining Potency for LNP-Delivered Gene Therapies: From mRNA to Function
Innovative Technologies in Gene Therapy Looking to Advance Vector Characterization & Genome Integrity
2:25 pm Session Reserved for Intertek
2:55 pm Advancing Molecular Techniques for Vector Characterization in Heterogenous Capsid Populations
3:25 pm Afternoon Break & Poster Session
4:25 pm Ensuring Genome Integrity in Gene Therapy with Advanced Tools & Techniques
4:55 pm Ensuring Consistency in Measured DNA Concentration while Transitioning from qPCR to Advanced PCR Methods
Physicochemical Properties
Advancing Analytical Methods for Complex Gene Therapy Products
11:45 am Making AUC GMP-Ready: Optimizing for QC & Regulatory Use
12:15 pm Aggregation Analysis in AAV: Selecting Fit-forPurpose Assays
12:45 pm Lunch Break & Networking
1:45 pm Shining Light on Mass Photometry: Applications & Analytical Challenges in Gene Therapy
Defining & Controlling Product Quality to Ensure Safety, Consistency, & Compliance
2:15 pm Session Reserved for Mirus Bio
2:45 pm From Bench to QC: Streamlining Potency Assay Readiness
3:15 pm Afternoon Break & Poster Session
4:15 pm Aging Like Fine Champagne: Ensuring Consistent Quality with Reference Standards
4:45 pm Establishing Infectious Titer Assays with Accuracy & Confidence
5:15 pm Chair’s Closing Remarks
5:20 pm End of Conference Day One