Developing high-quality starting materials for advanced therapies involves several key stages. It begins with sourcing from a diverse donor pool to ensure a broad and reliable foundation. Early characterization is conducted using phenotyping, cell quality metrics, and cell numbers to assess initial material quality. Conditions are then optimized for collection methods, shelf life, and preservation to maintain purity. Advanced characterization links phenotypic, genomic, and functional traits to clinical outcomes, providing deeper insights. Strategic variability control ensures consistency through well-defined donor selection criteria and standardized processing steps. Finally, life cycle management ensures product consistency by balancing characterization and release assays, meeting Critical Quality Attributes (CQA) for therapeutic applications.
