The rise of personalized medicine is promising for patients, but poses tremendous challenges around cell and gene therapy manufacturing processes.
For starters, the raw materials are the patients’ own cells. In traditional drug manufacturing, chemical ingredients are standardized, but in personalized medicine, every patient’s cells are unique. Some individuals have been through multiple rounds of other treatments. Others might be healthier. No matter what, each batch requires a custom approach and careful tracking to ensure safety and efficacy.
During an industry panel held last fall, experts shared their experiences grappling with this revolutionary approach to medicine.
“We need to understand that if my material is different, then I need to change my recipe to get the same result,” explained one manufacturer.
It’s a long, complex process. “The business model viability is at risk,” one participant noted. “We’re not treating enough patients.”
Solving the manufacturing challenges isn’t about forcing standardization into the process. It’s about creating processes flexible enough across all of the industries involved to handle natural variation while delivering consistent, life-saving treatments.
Industry leaders are working to strike these balances and scale up production while maintaining the personalized nature of these treatments.
And everything needs to be tracked meticulously to ensure each patient receives their own cells back.
Companies are adopting platforms designed to manage this complexity, integrating patient and product data across the supply chain to produce the best outcomes for patients. They’re also looking at ways AI can improve predictability.
In 2025, life sciences companies are making strategic investments in areas like CDMO partnerships, end-to-end supply chain visibility, and generative while advancing personalized therapies and precision medicine.
When patients have weeks or sometimes just days, expecting them to wait while their treatments traverse the country simply isn’t viable. “We can’t build hospitals around centralized manufacturing units,” a panelist noted.
Most advanced cell therapies are made in a handful of centralized facilities, creating a logistical puzzle that can mean the difference between life and death.
Industry leaders are working to improve patient access to cell and gene therapies by decentralizing the manufacturing process.
Of course, this brings up some questions. How do you ensure a therapy manufactured in Boston is identical to one made in San Diego? The answers are emerging through centralized quality control systems and automated processes. “It’s about process consistency, not just product consistency,” a panelist said.
One expert predicted that in five to ten years, this could look more like the current blood center network. Equipment arrives, does its job with minimal human intervention, and a life-saving treatment is ready for the patient. No complex shipping logistics, no race against time – just efficient, local delivery of personalized medicine.
Standardization has big benefits when it comes to improving life sciences R&D by streamlining interactions with contract manufacturing organizations.
Amid all the technical challenges, the industry panel kept returning to one crucial point: there’s always a patient waiting at the end of the process.
The path forward requires balance— between automation and human oversight, between standardization and flexibility, between protecting proprietary information and sharing data that could benefit everyone.
For patients fighting against time, these improvement can’t come soon enough. The science of cell and gene therapy is remarkable, but getting these treatments to patients quickly and reliably will be the real breakthrough.
