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