Audit Ready Every Day: Embedding Quality Into Cell Therapy Manufacturing

By Melodie Bryce, VP, Global Head of Quality

As cell therapy manufacturing matures, rising regulatory expectations make pre‑approval inspection readiness essential—not a last‑minute exercise, but a foundational way of operating. Many inspection delays stem from avoidable issues such as incomplete potency strategies, weak traceability controls, insufficient raw material qualification, and gaps in aseptic processing. Most problems emerge when early‑phase flexibility morphs into undocumented, ad hoc practices that fail to stand up to scrutiny during later filings.

To avoid these setbacks, manufacturing organizations must build quality into daily operations. This includes aligning potency strategy with mechanism of action, ensuring end‑to‑end traceability from donor through administration, and rigorously managing starting materials. Robust contamination control—supported by environmental monitoring, media fills, and well‑defined open‑manipulation procedures—is equally critical.

Because cell therapies are inherently variable, teams must plan for ambiguity by defining clear decision points in batch records and creating pathways for escalation when quality characteristics fall outside expected ranges. Phase‑appropriate approaches must still be reproducible, controlled, and defensible. Reliable methods, validated at the right time, support comparability and reduce the risk of costly redevelopment.

True inspection readiness means living quality every day—embedding accountability, documenting procedures clearly, and ensuring that operations remain consistent whether or not an inspector is present.