Scaling CAR-T: The hidden challenge of thousands of patient-specific manufacturing runs

Legend Biotech and Johnson & Johnson’s Carvykti therapy illustrates the personal connection patients have with CAR-T, but also its unique operating model where each commercial dose is linked to an individual patient.

Since its first approval in 2022, Carvykti has generated $657 million in second-quarter net sales, a 50 percent increase year-over-year, and is now offered at 348 sites in 19 markets.

The core bottleneck remains the need to run thousands of separate manufacturing batches for each patient, coordinating cell collection, manufacturing slots, quality testing, release timing and logistics, rather than scaling a single large batch.

Researchers suggest that "in-vivo" production approaches, which would generate the engineered cells directly inside the patient, could help overcome the scale-out limitation.