Kashyap Pandya

Company: PTC Therapeutics

Job title: Associate Director - Analytical, Chemistry, Manufacturing, Controls & Gene Therapy

Seminars:

PANEL: Comparing Traditional Methods for Aggregation Analysis & Effective Safety Profiling 12:00 pm

Comparing DLS, vs Size Exclusion Chromatography vs Asymmetrical Flow Field-Flow Fractionation to determine orthologous methods that can be used to increase the accuracy of profiling aggregates Using aggregation analytical tools to determine whether empty or full capsids more prone to aggregation Discussing the regulatory expectations on aggregation to inform what areas of aggregation formation should…Read more

day: Day One AM - B

ROUNDTABLE: Accelerating Cell-Based Bioassays for Robust Safety Assessment that Meets Regulatory Demands 2:45 pm

Introducing strategies to expedite the replication competent AAV qPCR assay timeline without compromising sensitivity Brainstorming techniques for overcoming detection limitations, increase the sensitivity of the assay and, enhance the detection of replication competent AAV Understanding regulatory guidelines surrounding rcAAV and residual WT AD5 safety testing to guide method development and implementation Determining the emerging role…Read more

day: Regulatory Focus Day