A mid-size cell therapy company who had just submitted their first BLA asked for a full onsite Pre License Inspection with inspectors and reviewers who had just left the agency and had extensive cell and gene therapy experience including BIMO. Their goal was to see where they stood on this first in kind therapy with unique turnaround time challenges for sterility testing as well as running the back-room audit support team and SMEs through a full inspection
PQC provided a week onsite, identifying several critical observations in aseptic processing, EM approach, data integrity, utilities, and QC methods with sufficient time to obtain a First Time Right PLI from CBER.
