Best Practices For Managing The Logistics And Distribution Of Cell And Gene Therapies

Cell and gene therapies represent a $63 billion market opportunity, but their commercial success hinges on mastering distribution complexities that standard pharmaceutical logistics can't address. Temperature requirements alone span from cryogenic (-150°C) to room temperature, and a site certified for one CAR-T therapy may lack the infrastructure for another therapeutic area entirely.

The real challenge isn't just cold chain management—it's understanding how your product's price point influences site participation, how quarterly formulary committees can delay access, and why packaging decisions made today will determine FDA approval timelines tomorrow. Cross-functional collaboration becomes critical when legal, regulatory, clinical, and supply chain teams each see only fragments of the picture.

From navigating J-code requirements before launch to stress-testing logistics flows with every stakeholder who'll touch your product, these operational realities separate successful commercialization from costly delays that affect patients waiting for life-saving treatments.