Operational Readiness
& GMP Enablement

PROJECT OVERVIEW

CAI supported the operational readiness of a clinical and commercial-scale cell and gene therapy
CDMO transitioning from a non-GMP environment to a fully GMP-ready facility. The engagement
focused on Validation, Process Engineering, MSAT, Quality Assurance, and the development of
a comprehensive Contamination Control Strategy to accelerate GMP compliance and enable
advanced therapy manufacturing.