The Evolving Role of Blood Centers in Delivering Characterized Starting Material for CGT Manufacturing
- Moving starting material characterization upstream in the CGT workflow – Immunophenotyping of leukapheresis starting material at the point of collection provides earlier insights into leukopak composition and immune subset variability, helping developers better understand manufacturing inputs, establish acceptance criteria, and support more consistent and predictable cell therapy manufacturing outcomes
- Standardization across decentralized collection networks – Perspectives from leading blood centers participating in a multicenter immunophenotyping study focused on reproducibility, harmonization, and scalable collection and streamlined characterization workflows
- Delivering more actionable starting material data to developers – How characterized leukapheresis products and standardized QC approaches can support manufacturing decisions, reduce variability, and strengthen developer–collector partnerships