Navigating Commercial Logistics: Key Considerations for Emerging Cell and Gene Therapy Manufacturers
Each therapy introduces its own mix of temperature requirements, delivery timelines, dosing protocols, and patient-specific matching considerations. Although certain processes can be standardized, every product requires a degree of customization. Whether it is the number of vials per treatment, HLA matching, or delivery to nontraditional sites like community clinics or patients’ homes.
Over the past eight years, Cencora has supported six CGT product launches and has gained critical insights into what it takes to scale from clinical development to commercial availability.
“There’s no endpoint to launching these cell and gene therapies,” says Krystal Haynes, Senior Director of International 3PL Business Development at Cencora ICS. “There’s going to be continuous change, so flexibility and nimbleness will be required.”
Drawing on that experience, Cencora’s logistics experts offer a roadmap for emerging CGT manufacturers preparing to bring their first therapy to market.
Keep patients at the center
Successful launches start with a strong foundation built not only for regulatory and operational success but also for meeting urgent medical need. “It’s not just about revenue. It’s about supporting a patient’s medical needs reliably, compliantly, and on time,” Haynes explains. A therapy may be first-in-class or supported by strong demand, but if it does not arrive safely and on time, the impact to the patient and the brand can be significant.
Establishing a logistics strategy that consistently delivers for patients requires early planning, clear roles, and trusted partnerships across the supply chain.
Plan for disruption
“I believe it’s vitally important to incorporate redundancy into critical supply chain components, such as validated thermal packaging, temperature monitoring systems, and safeguards for cold chain continuity,” says Eric Schier, Senior Manager of Personalized Supply Chain at Cencora World Courier. In addition to technological safeguards, Schier maintains that route risk assessments should be conducted in advance to ensure alternate pathways are available if the primary plan fails. “Contingency planning builds a wider safety net that helps ensure continuity of care even when the unexpected occurs,” says Schier.
Integrate digital infrastructure
“Information has to travel freely and transparently, as well as safely,” says Schier. “End-to-end digital integration is where this industry is going.”
Digital tools can help overcome many of these barriers, enabling real-time visibility into product location, condition, and timing. This is especially critical for autologous therapies, where chain of identity and custody must be meticulously maintained to ensure that patients receive the exact therapy manufactured for them.
At a minimum, Schier advises implementing real-time tracking to monitor both temperature and location. As more advanced systems are adopted, manufacturers should also prepare their partners and internal teams for change through training and cross-functional coordination. Change management initiatives must show the value added and include retraining when needed.
Design for Scale
Cencora’s logistics team has seen firsthand how quickly volume can grow once a therapy is approved. In fact, every CGT launch they have supported has experienced a sharp acceleration in demand.
“Every therapy we have launched at Cencora has seen this hockey stick effect,” says Haynes. “Sometimes the forecast is accurate. Other times, growth exceeds it dramatically.”
Scalability should be built into the logistics model from the beginning. Infrastructure, processes, and partner capacity all need to be flexible enough to absorb increased demand. Forecasting models should also extend at least three years beyond launch to help anticipate resource needs and manage distribution volumes. Just as importantly, teams should adopt an agile mindset. “Regulatory complexities will change. Shipping systems will evolve. Your partners will evolve again,” says Schier. “Stay agile.”
Prepare for Global Expansion
“Once you go into emerging markets, you’re going to have to partner with somebody,” says Schier. He adds that if a manufacturer’s partners are not aligned with the required competencies, the result can be repeated setbacks. “It’s a lot of redo, redo, redo. It’s a no-win scenario unless you’re aligned.”
Choosing the right partner with demonstrated experience in CGT launches is critical for success across borders. A good partner can get products into new geographies while maintaining the consistency and integrity that patients and regulators demand.
Build together, do it right the first time
“We encourage workshops,” says Haynes. “You have to sit down and talk about expected and unexpected outcomes. There’s a ‘hip-to-hip’ conversation that needs to happen where we harness the brainpower of people who’ve been through this before.”
The ideal time to begin this collaboration is 12 to 18 months before launch. Early alignment allows for infrastructure build-out, process validation, and training across stakeholder groups.
“Launch success is a one-time opportunity,” says Haynes. “Let’s launch effectively and then let’s dream together.”
With six CGT launches behind them, Cencora’s team continues to evolve its support models, but the mission remains clear. Schier adds: “Control what you can control. Apply a robust risk management strategy to help mitigate risk. And don’t lose focus of why we all do this. It’s to ensure that hope is delivered to our patients.”
For more recommendations on how to manage logistics when commercializing a cell or gene therapy, see the recent guide, Creating a compliant and scalable CGT logistics launch plan
Disclaimer: This article may contain marketing statements and shall not constitute legal advice. Cencora, Inc. strongly encourages readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related theret
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