New ISCT Thought Leadership Explores Why Growth in CGT Demands a Different Operating Model 

The way the industry thinks about scale is starting to shift. For decades, growth in biopharmaceutical development has followed a familiar pattern. As programs advance, manufacturing expands and throughput increases, allowing therapies to move from limited, early-phase clinical trial settings into broader patient populations. Scale has traditionally been defined by how much can be produced, how efficiently, and how consistently over time.  

But in cell and gene therapy (CGT), those assumptions are being challenged.  

A new article from Cryoport Systems published through the International Society for Cell & Gene Therapy (ISCT) explores how scale behaves differently in advanced therapies and why the industry may need to rethink the operating models used to support it.  

Unlike traditional biologics, personalized therapies can’t be expanded through larger batch production. Each dose is patient-specific, tied to an individual timeline and chain of identity, custody, and condition that must be maintained from collection through administration.  

As a result, scale doesn’t come from producing more at once. It comes from performing the same highly controlled N-of-1 process across a growing number of patients. In other words, CGTs scale out, not up. And this scale-out dynamic introduces a different kind of complexity, one where growth multiplies processes rather than extending them.  

Read the full article: “Scale Has Changed Shape for Cell and Gene Therapy”