Roundtable: Implementing Functional QC Frameworks to Predict Potency & Reduce Line-to- Line Variability Early in Development

• Using functional assays to assess differentiation, proliferative potential and therapeutic relevance early, reducing downstream manufacturing and clinical failure risk
• Addressing the industry-wide gap in functional characterization defining what must be measured preclinically to ensure products are safe
• Building QC systems that de-risk variability across clones, donors, and maturation states, ensuring controlled, predictable behavior before entering GMP workflows

Speakers:

Yanzheng Liu

Senior Director - Quality Control

Aspen Neuroscience

Eric Law

Head of Chemistry, Manufacturing Controls & Regulatory Affairs

Century Therapeutics

Mehmet Cilek

Scientist, Cell Therapy & Process Development Lead

SUNY Center for Advanced Cell Therapy, SUNY Upstate Medical UniversitySUNY Upstate Medical University