Best practices for managing the logistics and distribution of cell and gene therapies

Another important consideration is identifying which sites of care you plan to target and whether their infrastructure is suitable for your product.

For example, the temperature requirements for storing a CGT product can vary significantly from cryogenic temperatures (-150°C and below) to ultra-low temperatures (-70°C to -80°C) to refrigerated and controlled room temperature (2°C to 25°C)³. An early question is whether the sites in your network can store and manager your product at the required temperature. If not, what alternatives can you suggest or provide, such as partnering with a third party or equipping the site appropriate cold-storage infrastructure?

Furthermore, you should not assume that sites that are already certified to manage an existing CAR-T therapy for oncology patients will be equipped to treat patients in other therapeutic areas with a new CGT. While some sites may be able to leverage portions of their existing infrastructure, this will not be true across all sites of care. Conditions like autoimmune diseases often involve therapeutic areas with distinct care teams, different areas in a hospital, or even entirely separate facilities, each with their own resources and operational requirements.

Don’t assume your life-changing CGT will get the red-carpet treatment at sites of care. But have you engaged with site administrators, therapy advisory committees, or other procurement professionals to get your product on a site’s formulary? Decisions on high-cost therapies can take time, and often committees often meet quarterly or biannually. Don’t risk your product being held up by red tape.

Also, you should plan for the tactical considerations, such as ship-to locations and payment terms. Will your product be shipped to a third party or another part of the organization? What credit and returns policies do you have in place? If you have a restrictive returns policy or don’t offer extended payment terms to the sites, many will likely opt for just-in-time dose orders. While this approach can reduce returns, it can also increase operational burden on your supply chain and logistics teams as they work to deliver therapy on tight deadlines to meet patients’ needs.

The best practice here is to understand the site-of-care behaviors your policies and procedures incentivize.  

Overcoming the multiple challenges that a CGT will face requires cross-functional leadership. Decisions rarely exist in isolation and choices made in one area can create downstream effects elsewhere. You need to consider multiple factors that weigh on your product’s success. For example, how you package your therapy can also impact storage for you and your sites of care.

Adopting a cross-functional approach can be difficult to put into practice, especially in larger organizations where teams often operate in silos and are not accustomed to resolving issues together. Functions such as legal, regulatory, clinical, market access, sales, finance, patient operations, and supply chain may each see only part of the picture, making it easy for gaps or unintended consequences to go unnoticed. Without broad cross-functional involvement, teams may not surface the right questions early, increasing the risk that critical issues are discovered too late to address easily.

Establishing clear roles and responsibilities across these teams is essential, but so is ongoing, active collaboration. Regular, structured engagement helps surface questions early, align decisions across functions, and identify potential issues before they escalate into barriers during commercialization.  

As we have seen many times, labeling and packaging can significantly affect your regulatory approval and your commercial pathways, often requiring manufacturers to make changes that slow the regulatory process. For example, for therapies that must be shipped at cryogenic temperatures, regulators will scrutinize your packaging to make sure it can withstand those conditions.

One example involved a therapy that had to be used within 14 days of a Current Good Manufacturing Practice (cGMP) pack-out, where the FDA issued a requirement for a core pack label. Fortunately, this occurred before filing, allowing the company time to sort out its labeling requirements.

Furthermore, the many developments and complexities in this space require a deep understanding of timeline order cutoffs. This includes knowing how fast you can get the product out the door and the flight schedules to meet regulatory requirements. CGTs are very often life-saving medicines so the impact of labeling and packaging on timing can be critical.

Conducting a mock-label and packaging review can help identify gaps and prevent last-minute rework.  

Terminology may have different meanings across clinical, regulatory, logistics, and commercial teams, so it’s important to communicate clearly to support alignment and avoid friction.

For example, confusion often arises with title model programs, where a 3PL partner takes title of a product to handle distribution. While there is an industry standard for title, there are several different versions of title depending on your product requirements and the point at which ownership transitions from you to a 3PL provider. If you are using a title model solution, it is important to understand how that title model works and to be aware of all the parties involved in that transition of ownership. This is particularly important for manufacturers that are new to the market who aren't with an exclusive provider or limited network.

Another example where terminology can create confusion is with orders. This could mean a physician order, a prescription, a shipment request, a site of care purchase order, or a purchase order coming from your distribution partner.

Also, in the cryogenic space, there are nuances that can’t be easily explained or understood without proper communication. Clear and proactive communication doesn’t just build understanding of the supply chain’s complexities, it also builds trust.