Chien-Chung Chen

Company: Cabaletta Bio

Job title: Director, Analytical Development

Seminars:

Panel: Debating Best Approaches to Assess Potency Beyond Interferon Gamma 12:15 pm

Why was IFN-gamma considered the gold standard potency method?  What other readouts should be evaluated besides killing and IFN-gamma?  How best should we transition from early to late-stage/commercial control strategies? What data or responses are desired to support the addition of other readouts to control strategies? Read more

day: Day 1 Track C AM

Developing Reference Materials for Robust Lot-to-Lot Testing to Achieve Consistency Across Product Release 1:30 pm

An interactive discussion of challenges and practices to develop reference materials, as to maintain analytical method performance, to evaluate assay/process/facility comparability, and to ensure consistent product quality and efficacy. Key discussion points: Development of reference materials Characterization of reference materials Applications of reference materials in lot release of drug product intermediate and drug productRead more

day: Workshop F