Christopher Larson on the operational realities behind QC in advanced therapies
In cell and gene therapy, scaling is often framed as a technical problem—more capacity, more automation, more throughput. But in Quality Control, the challenge is rarely just technical. It is operational, and it becomes more visible as organizations grow. Systems don’t usually fail first. The breakdown happens in how people, processes, and information connect—or fail to.
Christopher Larson, former Vice President of Quality Control at Castle Creek Biosciences, has spent his career building and scaling QC organizations in some of the most complex environments in biotech. His perspective reflects a reality that emerges over time: as programs expand, maintaining discipline becomes harder, not easier, and the cost of misalignment increases with scale.
Where QC Breaks
One of the most persistent bottlenecks Larson sees is not a lack of capability, but a lack of connection between functions. “QC does not always have a complete understanding of what’s going on in manufacturing,” he explained. That gap becomes critical the moment something deviates from expectation.
“When we get weird results, how can we help to participate in that investigation if we don’t understand how that material was generated?” he said. In increasingly complex manufacturing environments, QC cannot operate as a downstream checkpoint. Without visibility into how materials are produced, even highly capable analytical teams are limited in how effectively they can interpret results or respond to issues.
What this reveals is a broader shift: QC is no longer an isolated function. It is part of an interconnected system, and when one part moves without the others, the entire system slows.
The Discipline Problem
As organizations scale, another pressure point begins to surface—one that is less visible but equally critical: discipline. Regulatory agencies are evolving, moving away from rigid, prescriptive requirements and toward more flexible frameworks. That shift creates space for innovation, but it also introduces ambiguity.
“It was easier to say… these are the rules, I’ve got to do these things,” Larson noted. “Now it’s kind of like, well, you don’t have to do that… but then you’re butting up against the BLA.”
The removal of strict guardrails doesn’t reduce the need for rigor. It transfers responsibility inward. Teams must now define their own standards, justify them, and ensure they hold under scrutiny. Without strong internal discipline, organizations risk advancing programs without fully validated methods, characterized products, or complete data packages—and by the time those gaps are discovered, the cost of correction is significantly higher.
How Teams Determine Outcomes
For Larson, navigating this complexity starts with how teams are built and led. In high-growth environments, technical expertise alone is not enough. What matters is whether teams can challenge assumptions, surface blind spots, and operate with a shared understanding of the system.
“It’s one, acknowledging that you don’t have all the answers,” he said. That mindset shapes how effective QC organizations function—not as rigid hierarchies, but as environments where input is expected and disagreement is part of the process.
“I want them to disagree with me… challenge me,” Larson emphasized. “Because we’ve got to figure this out together.” In systems where variability is high and timelines are tight, speed doesn’t come from control alone. It comes from alignment: teams moving with the same understanding, even as complexity increases.
The System Has Changed
Larson’s perspective reflects a broader shift across advanced therapies. As programs move from early development into later-stage and commercial environments, the demands on QC expand. The function is no longer just responsible for testing—it is responsible for supporting decision-making across the lifecycle.
That shift affects multiple layers of the system: QC teams navigating increasing complexity, manufacturing organizations operating under tighter timelines, leadership making decisions with incomplete information, and ultimately patients relying on consistent and reliable therapies.
Quality can no longer operate in silos. It must be integrated with manufacturing, development, and strategy from the beginning.
The Bottom Line
As cell and gene therapies scale, the challenges facing QC are becoming less about capability and more about coordination. Better systems alone are not enough. What determines success is how well those systems are understood, connected, and executed across teams.
Christopher Larson’s perspective makes that clear. At scale, quality is not defined by any single test or function. It is defined by how well the entire system holds together under pressure.
And the first thing that determines whether it does is discipline.
