What's Slowing The Journey From Therapy to Patient? Inside The Operational Hurdles Of ATMPs

Despite the accelerating pace of Advanced Therapy Medicinal Product (ATMP) approvals, a massive access gap persists—with only a fraction of eligible patients being treated. The core issue isn't the science; it's the structural limitations within the delivery system, including strained manufacturing capacity, cold chain infrastructure, and the complexity of coordinating care across various sites.

For patient-specific autologous therapies, successful delivery relies on tight synchronization from the first kilometer to the last, encompassing apheresis, manufacturing, and reinfusion. Delays from missed pickups or customs clearance can compromise the irreplaceable dose. Supply chain success today goes beyond simple temperature control; it demands Chain of Compliance rigor, real-time condition monitoring of metrics like orientation and shock, and robust contingency planning.

Resilience is a deliberate design choice. It requires building agile systems and strategic partnerships to effectively manage the complexities of global distribution and quickly pivot when faced with disruptions like a sudden site closure. Learn about the structural solutions and integrated services needed to move ATMPs forward without compromising the promise of the therapy.