Across the cell and gene therapy (CGT) industry, the race to bring life-saving treatments to patients is accelerating. Scientific innovation has outpaced infrastructure, and clinical breakthroughs are now bumping up against the realities of manufacturing execution. For CGT manufacturers, the most urgent question isn’t whether the therapy works—it’s whether it can be consistently, compliantly, and efficiently scaled. And that’s where the bottleneck lies.
Unlike traditional biologics, autologous CGTs are manufactured one patient at a time. Each therapy represents its own micro-batch, produced, tested, and released in isolation. This model demands an entirely new way of thinking about manufacturing—one that treats each patient as both the source and the destination of the product. There is no batch pooling, no redundancy, and no room for error. Each lot must be handled with forensic precision: identity tracked, chain-of-custody preserved, and release decisions made quickly and correctly, every single time.
Layer onto that the natural variability of human cells, which behave differently from one donor to the next. Even when following the same SOPs, yields can vary dramatically, and the potency profile of the final product may fluctuate. This isn’t a deviation from process—it is the process. And it places a crushing burden on process control, analytical sensitivity, and regulatory documentation.
Now, couple that with the fact that many CGT facilities were not built with commercial scale in mind. Processes remain largely manual. Batch records are still paper-based. Teams rely heavily on tribal knowledge rather than digital systems, and deviations are often managed reactively rather than proactively. In this environment, the quality systems struggle to keep pace, and tech transfer from development to GMP production becomes an exercise in risk mitigation rather than seamless execution.
For CGT manufacturers facing these pressures, it’s not enough to work harder—it’s time to think differently. The scalability problem is not just a technical one; it’s a strategic maturity challenge across the entire CMC landscape. That’s where QXP comes in.
QXP works alongside CGT companies to strengthen the foundational capabilities that enable scale. We assess CMC maturity with a phase-appropriate lens, helping organizations map where they are today—and where they need to be by the time their therapies hit pivotal trials or market launch. Our approach identifies bottlenecks across manufacturing sciences, quality systems, digital readiness, and regulatory strategy. Whether it’s designing a scalable tech transfer framework, implementing a fit-for-purpose QMS, or preparing a facility for PPQ, QXP provides the playbooks, tools, and expert guidance to drive readiness and reduce risk.
We don’t believe in one-size-fits-all solutions. CGT companies are pushing the boundaries of medicine, and they deserve partners who understand the nuance of these platforms. Our consulting model is rooted in operational empathy and regulatory foresight. We bring structure to complexity, helping leadership teams make decisions that are both compliant and commercially viable.
Scaling CGT isn’t about brute force—it’s about intentional design. With QXP’s support, manufacturers can move from fragile, artisanal operations to robust, responsive systems capable of delivering cell and gene therapies to patients at scale. The science is already revolutionary. Now it’s time for the manufacturing strategy to catch up.
