Building Quality At The Source: Overcoming CGT-Specific GMP Challenges

In the world of Cell and Gene Therapy (CGT), quality isn’t just a metric—it’s a mission-critical imperative. Unlike traditional pharmaceutical manufacturing, where millions of identical tablets are produced in a single batch, CGT operates on an entirely different scale and philosophy. Here, every batch is often tailored to a single patient, making it a “batch-of-one.” This personalized approach transforms the quality landscape, introducing a level of complexity and urgency that traditional models rarely encounter. What makes CGT quality management so uniquely demanding? First, the production model itself is inherently individualized—each patient represents a unique batch, and there is no room for error. The starting materials, often derived from the patient or a donor, vary significantly from case to case, introducing biological variability that must be carefully managed. Time is another critical factor; therapies must often be manufactured and delivered within extremely tight windows, where delays of even a few hours can compromise efficacy or safety.

In this high-stakes environment, traditional quality systems simply aren’t enough. CGT demands a new paradigm—one that is agile, precise, and deeply integrated across every stage of production. If you're navigating the complexities of CGT manufacturing, now is the time to reimagine your quality strategy.