David Schwalb

David Schwalb

Company: Pacira Biosciences

Job title: Director, Analytical Development, Cell & Gene Therapies


PANEL DISCUSSION: HPLC & Mass Spectrometry-Based Approaches: Are they Worth Integrating into Your Overall Potency Strategy? 2:30 pm

Weighing up the relative advantages and disadvantages of using mass spectrometry and HPLC tools to assess potency and inform assay suitability Evaluation the impact of these technologies on reducing variability, managing time-consuming readouts, and ensuring sample stability Where do current methods face limitations in their capacity to detect functional activity alterations? Highlighting the need for…Read more

day: Day 2

Determining the Relative Importance of Identity Vs Functional Potency Assays Throughout Early to Late-Stage Potency Assay Development 9:00 am

Evaluating the calculated risk involved in initiating potency assay development early in clinical phases (phases 1 and 2) to mitigate comparability challenges Identifying the importance of early identity potency assays for CMC compliance Highlighting the increasing expectations from regulators for potency assessment at all phases of clinical developmentRead more

day: Day 1

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