Building a resilient supply chain for cell and gene therapy manufacturing

Advancements in manufacturing have the potential to significantly improve the cell and gene therapy (CGT) landscape in terms of efficacy, quality, scalability, and patient access. However, it requires a rethinking of traditional supply chain dynamics and operational workflows, according to panelists at the 2025 Cell & Gene Meeting on the Mesa in Phoenix.

Panel chair Priya Baraniak, chief commercial and development officer at Pluristyx, noted that the CGT industry is at an inflection point, while at the same time the sector is confronting a paradox: how does it build a robust, industrial-scale system for what are in many cases one-patient-one-product therapies?  

Tuesday’s panel discussion highlighted the fact that the industry’s inability to make products efficiently and at-scale is due largely to the complexity of the CGT supply chain.

“There is no one-size-fits-all answer for this industry,” Baraniak said, pointing out that autologous therapies have considerations that are fundamentally different from "off-the-shelf" allogeneic products, while cell therapies differ from gene therapies.

When it comes to infrastructure, centralized manufacturing provides the benefits of standardization and scale and decentralized, point-of-care manufacturing offers speed, agility, and new opportunities for access, according to Baraniak.  

The panel discussed strategies in managing raw and starting materials, with centralized manufacturing given the advantage over decentralized in ensuring consistency given the inherent variability of autologous starting materials. However, cell-based therapies generated using a patient's own cells that are delivered to a manufacturing facility and then back to a clinic are potentially prone to damage, loss, and risk of cross contamination.

While decentralized manufacturing could improve CGT access by addressing issues related to the high cost of production, scale, and distribution, the panelists agreed the most likely situation over the next 10 years is a hybrid ecosystem of both the centralized and point-of-care manufacturing models.

“A lot of times, we tend to think in very black and white or binary in this industry — it’s either autologous or allogeneic, it’s centralized or decentralized,” Baraniak said. “There’s so much uniqueness in each of these processes, each of these products, and the patients we're treating, that it’s really all of the above.”

Asked what the biggest challenge is in scaling CGT manufacturing that the industry isn’t talking about enough, Asimov co-founder Raja Srinivas warned that the “Wild West” in the sector is the product quality of adeno-associated virus and lentivirus vectors.

“We don’t know what the product quality metrics are,” Srinivas said. “Why that matters for scaling the supply chain is because if you don’t know your batch consistency, you’re taking a big risk.”

To be able to scale CGT manufacturing, the industry needs better ways to control and measure product quality to “make sure that every single dose we give to a patient is exactly the same as the one that was approved from a regulatory standpoint,” Srinivas added. 

Kevin Chinn, vice president and head of cell and gene service line at Cencora, commented that one area that is often overlooked are “all the other pieces that touch manufacturing” including logistics, storage, transportation, and tracking. Having visibility into the touch points such as chain of custody are critical, according to Chinn, who likened it to the role of an air traffic controller.

“Geography makes a difference,” Baraniak said, as the CGT industry looks to build a resilient and patient-centered supply chain aimed at timely, consistent delivery. “Getting something to a sub-Saharan patient is very different than getting that to someone in say London or New York City and the cold chain and the logistics around it. There are so many considerations for us as an industry.”