ICH E6(R3) In Effect: Transforming Quality Management For Cell And Gene Therapy Trials

Cell and gene therapy developers are navigating a period of unprecedented growth, yet manufacturing capacity still lags far behind projected need. The arrival of ICH E6(R3) offers a timely shift for teams working to scale safely and efficiently. Its principle‑based framework moves away from rigid, checklist-driven expectations and instead emphasizes quality risk management—an approach far better suited to the complexity and variability of CGT processes.

Explore how developers are applying these updated expectations to streamline workflows, strengthen data integrity, and build more adaptive quality systems. Gain insight into the digital tools and connected platforms that are helping organizations reduce errors, accelerate batch release, and support quality‑by‑design thinking from early development through commercial production.

For teams preparing their next phase of scale-up, this is a practical look at aligning operations with ICH E6(R3) while protecting speed, quality, and patient impact.