As your cell or gene therapy operations scale from early-phase clinical trials to larger populations in late-stage trials and commercialization, your supply chain complexity — and risk — increases. Anticipating common setbacks and actively planning for their solution requires a specialized and collaborative approach with your supply chain partner.
Keep these key considerations top of mind as you evaluate whether potential partners have the experience, expertise and relationships required for the successful transport and delivery of your cell or gene therapy.
- Cell and gene therapy shipment volume
Cell and gene therapy shipments have inherent challenges that are unlike traditional pharmaceutical drug shipments. Your cellular starting material or manufactured product must be delivered where it needs to go, when it is expected to get there, and in the required condition and temperature. A patient’s life depends on it.
That is why shipment volume — and experience gained over time — is so important especially as you transition from smaller early-stage clinical trial volumes to larger volumes. Supply chain vendors who routinely coordinate logistics for time-critical allogeneic and autologous cell therapies understand how to overcome cell and gene therapy shipment challenges.
When evaluating cell or gene therapy shipment volume, ask:
- How many cellular therapy product shipments a year does your organization manage?
- How many total cellular therapy product shipments has your organization managed?
- On average, how many cellular therapy product shipments a day is your organization tracking?
- What is your company’s annual volume of fresh product shipments? What is your company’s annual volume of cryopreserved products?
- What volume of cellular therapy product shipments managed by your company cross international borders?
“We’ve learned to overcome challenges inherent to shipments for cell and gene therapies. And we’ve done so more than 100,000 times. For almost any anomaly, we’ve seen something similar before. And we’ve found a way to overcome it to save someone’s life.”
—Ray Hornung, MBA, CEM, CBCP, Senior Manager, Logistics and Emergency Preparedness, Be The Match BioTherapies®
Company experience overcoming logistics challenges
Every day, shipments go exactly as planned. But when issues arise and a person’s life relies on your product, your vendor’s systems, processes and relationships to reroute, problem-solve and deliver are critically important.
Those systems, processes and relationships are not developed overnight. For example, our more than 60-person Cell Therapy Supply Chain and Logistics Management team relies on the experience gained over 30+ years. In that time, they’ve coordinated logistics for more than 100,000 time-critical cellular therapies to successfully overcome challenges. That includes more than 6,500 cell therapies annually.
When evaluating a cell therapy supply chain vendor’s experience, ask:
- How many years of experience does your organization have providing logistics to cell and gene therapy developers?
- What is your process for enacting your emergency preparedness or disaster recovery plan?
- How does your company handle changing a product itinerary mid-travel due to a supply chain disruption that can’t be avoided?
- What experience does your company have managing logistics during a natural disaster or geopolitical event?
“Experience is a big benefit for cell and gene therapy developers. Orchestrating cell therapy logistics is more complicated than most people realize. These shipments are life critical and they can’t be replaced. There is no room for error.”
Cell Therapy Supply Chain Manager oversight
Even with a well-designed logistics plan and an experienced team, supply chain disruptions will happen. For example, a collection may take longer than expected causing a pick-up delay or a natural disaster may impact flights.
That makes a dedicated Cell Therapy Supply Chain Manager an essential member of your vendor’s supply chain team. Cell Therapy Supply Chain Managers work with their team and yours to build contingencies into itineraries. They also troubleshoot any issues that arise.
A Cell Therapy Supply Chain Manager should be available 24/7. They must be ready to take action and keep all stakeholders informed about revised plans.
When evaluating a vendor’s Supply Chain Management team, ask:
- How large is the team that will support the logistics activities for our product? Who are the team members?
- Does your company provide after-hours, weekend and holiday on-call support to manage unexpected changes and emergencies?
- What is your company’s escalation process to manage and communicate delays or changes to schedule?
- How and when will your company communicate schedule changes to us?
- Is your team solely dedicated to managing the supply chain for cell and gene therapy products?
“We have someone available 24/7 to ensure the people transporting our products have the knowledgeable support of the organization behind them.”
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Established domestic and international relationships
Some challenges, like severe weather, customs complexities and flight delays, can’t be avoided. Building key domestic and international relationships in advance lessens your risk and variability within the supply chain.
Look for a partner that has relationships with people and organizations across the supply chain. For example, our team has relationships with customs brokers throughout the world. These brokers help us manage and resolve border crossing challenges and ensure the correct import and export documentation is in place.
A supply chain partner should also have:
- Strong relationships with emergency preparedness teams at all levels of government
- Connections to government agencies
- Access to chartered forms of transport and a robust business continuity team
A case in point: The COVID-19 pandemic. Throughout the pandemic, our team members have continued to successfully deliver life-saving cell therapies globally. They’ve done so every day despite major travel challenges.
In fact, when international borders closed, our strong government relationships allowed us to obtain a CDC waiver. The waiver allows foreign nationals to deliver cell therapy products into the United States. With nearly 60% of our products crossing international borders, the waiver was critical to our operations.
When evaluating a vendor’s domestic and international relationships, ask:
- What processes and relationships do you have in place to overcome border-crossing issues for cell-based products?
- Can you provide me with specific examples of your company’s relationships with domestic and international agencies?
- How has your company used your relationships with domestic and international agencies to manage logistics during a natural disaster or geopolitical event?
- Does your organization have an emergency response team in place to mobilize in the case of events that could negatively impact the transport of cellular products?
“A lot of what we do isn’t just systems-based, it’s also relationship-based. The only way we can be as successful as we are is by leveraging the relationships that we maintain across the country and across the world.”
Expansive supply chain infrastructure
Building an expansive infrastructure to collect your starting material and move that starting material or your final therapy from one location to another is costly, labor intensive and requires specialized expertise.
A supply chain partner should have extensive partnerships with commercial couriers to move your starting material and manufactured product. For example, we work with multiple commercial couriers. This allows us to accommodate pick-up needs and our volume of shipments allows for priority loading.
When evaluating a vendor’s supply chain infrastructure, ask:
- Is your company courier agnostic (i.e., do you work with multiple commercial couriers)?
- How many courier companies does your organization use for moving cellular material both domestically and internationally?
- How does your company choose a courier for a given transport leg? What considerations go into that decision?
- Describe the relationship between your logistics staff and the couriers. What processes do you use to rectify issues when they arise?
- What experience does your company have providing a high-touch service, such as a hand-carried courier service?
- Do your shipping lanes allow for customized itineraries or do you only transport product through specific airports or hubs?
“We have proven experience and extensive relationships that have continually evolved as the cell and gene therapy landscape has expanded. That’s the biggest advantage cell and gene therapy companies have when they tap into our expertise.”
A supply chain partnership you can count on
Over the last 30 years, our team has developed a proven supply chain infrastructure to more efficiently deliver cell and gene therapies.
Since our inception, we’ve coordinated the collection of cells and delivered those cells to manufacturers and waiting patients around the world. That includes more than 100,000 cellular therapies total and more than 6,500 cell therapies annually.
We’ve developed the systems, processes and relationships needed to overcome unexpected challenges in the U.S. and abroad. We did it so you don’t have to. Rely on our team to minimize your risk.