Considerations for mRNA-LNP Potency Assay Development for Gene Editing Products

First talk: Considerations for mRNA-LNP Potency Assay Development for Gene Editing Products

• Overview of matrix approach for potency assay development 

• Review of available regulatory guidance and expectations for phased-based approach to potency assay development 

• Tools and considerations when measuring biological cascade of RNA & LNP delivery in-vitro 

• Challenges associated with potency assay development for gene editing products  

Presented by Benjamin Hall, Associate Director in Analytical Development at Tessera Therapeutics

Benjamin Hall is currently an Associate Director in Analytical Development at Tessera Therapeutics where he leads potency assay development for Tessera’s Gene Writing products. Previously, Benjamin worked at bluebird bio and 2seventy bio in Analytical Development where he supported analytics, potency assay development and regulatory filings for autologous cellular therapies Zynteglo and Abecma. Benjamin has his B.S. in Biology from Boston College.  

Second talk: Advancing the Analytical Characterization of mRNA-LNPs using Capillary Electrophoresis

• Overview of analytical characterization methods for mRNA-LNPs 
• Utilizing icIEF technology to assess identity and stability using charge separation analysis 
• Improving the separation of LNP samples by optimizing solubilizing conditions 
• Assessing multiple attributes including stability, lipid composition variations, surface charge heterogeneity, packaging efficiency 

Presented by Gargi Chaudhuri, Ph.D., Senior Field Applications Scientist, Bio-Techne (Protein Simple) 

Gargi Chaudhuri, Ph.D., is a Senior Field Applications Scientist and technical lead specializing in Maurice™ (CE-SDS, icIEF, and cIEF), MFIandSimple Western™ (Jess™, Leo™, and Peggy Sue™) platforms for automated protein characterization. She has extensive hands-on experience developing and optimizing workflows for protein purity, size, and charge heterogeneity analysis, antibody validation, and biotherapeutic characterization. Gargi partners closely with pharma and biotech customers to drive application adoption, workflow optimization, and scientific success. She supports complex customer applications through method development, assay troubleshooting, and data interpretation, while leading instrument demonstrations and trainings for pharmaceutical and biotechnology partners. She holds a Ph.D. in Genetics and is based in Boston.

Followed by a live Question and Answer session

Sponsored by Bio-Techne

ProteinSimple (part of Bio-Techne) provides cutting-edge analytical instruments designed to simplify and expedite protein research. Our innovative technologies deliver deeper insights, improved reproducibility, and faster decision-making, empowering scientists to advance their discoveries with greater precision and efficiency.