Q&A: Quality Agreements, Tech Transfer, And Risk Management In Cell And Gene Therapy

As advanced therapies move quickly toward clinical use, there's far less room for missteps, which puts early, thoughtful quality planning front and center. Instead of acting as a final checkpoint, quality teams now need to be involved from the start—helping shape process design, manage risks, and support smooth technology transfer. The complexity of living systems, the ever‑present risk of contamination, and the need for reliable long‑term data all demand decisions based on solid scientific understanding, not last‑minute fixes.

Clear, well‑built quality agreements play a major role in keeping partners aligned. They outline who makes decisions, how deviations are handled, how changes are managed, and how issues are escalated. Bringing quality teams into tech transfer early helps prevent delays because the focus shifts from moving documents around to sharing actual process knowledge. The conversation also underscores how digital tools and AI can strengthen oversight and forecasting—so long as they're grounded in accurate, well‑managed data.

The takeaway is straightforward: when quality is built in from day one, programs scale more smoothly, regulators gain confidence, and patients ultimately benefit.