Scenario A.
Understand & Prioritize	Optimize Implementation	Finalize Testing & Enhance Surveillance
Starting material Source	Supply Chain	Global distribution
Proper Cell Characterization & Analytics	Impurities	Satellite centers for product testing
Scalability	Aseptic processing	Potency Assay
Raw materials controls	Final container
Process consistency: yield & failure mode	Potency assay
Definition of critical quality attributes relate to MOA	Sterility testing
Potency Assay	Equipment Enhancement
Cell preservation
Facility needs & cost
Stability, Transport & tracking
Release Assays
Tools and protocols for patient delivery (non-GMP)