Part 28 of our Bridging the Gap Series (Summary of the webinar session held in March 2026)
For all the progress in cell and gene therapy, getting these treatments to patients remains one of the field’s greatest challenges. Today, only a fraction of eligible patients are able to access these therapies—often due not to science, but to limitations in manufacturing, cost, and infrastructure.
Cell and gene therapies depend on specialized manufacturing, complex logistics, and infrastructure that exists in only a small number of places. As a result, they are often only available at certain treatment centers, and patients may face delays before they are able to receive them.
Addressing this gap – how to manufacture and deliver these therapies more broadly – was the focus of our recent Bridging the Gap webinar hosted by George Eastwood of the Emily Whitehead Foundation. The discussion featured Dr. Boro Dropulić, Co-founder and Executive Director of Caring Cross and CEO of Vector BioMed, Tom Whitehead, Co-founder of the Emily Whitehead Foundation, and Dr. Patrick Hanley, Chief and Director of the Cellular Therapy Program and an Associate Professor of Pediatrics at Children’s National Hospital and George Washington University.
From Early Gene Therapy Research to CAR-T
The technologies behind today’s CAR-T therapies trace back to early gene therapy research. In the late 1980s, Dr. Dropulić began working at the National Institutes of Health, when researchers were exploring how viruses could be engineered to deliver therapeutic genes into human cells. His work focused on viral vector systems, which later became foundational tools behind many modern cell and gene therapies. These early advances underpin the same technologies now shaping how therapies can be scaled and delivered more efficiently today.
Dr. Dropulić later founded Lentigen, the company that developed the lentiviral vector used to manufacture Kymriah®, the first CAR-T therapy approved by the U.S. Food and Drug Administration.
What it Takes to Make a CAR-T Therapy
Even with advances in viral vector systems, access to cell and gene therapies continues to be out of reach for many patients. Because each treatment is created from a patient’s own immune cells, producing a CAR-T therapy can take weeks. Cells are collected, genetically modified, expanded in specialized facilities, and then returned to the hospital for infusion. For patients with aggressive disease, this waiting period can be critical. In some cases, patients may not be able to wait long enough to receive treatment, highlighting the need for faster and more flexible manufacturing approaches. This has led researchers to explore new manufacturing models that could shorten the time between cell collection and treatment.
For patients with aggressive disease, manufacturing timelines can become a critical barrier to treatment.
Manufacturing timelines are only part of the challenge. Producing a CAR-T therapy is also resource-intensive. During the panel discussion, speakers noted that the materials required to produce a CAR-T treatment can total around $20,000, including viral vectors and other reagents, while labor and facility costs can add another $20,000 to $30,000. While these figures represent only part of the total cost, they highlight a stark contrast with the list prices of approved therapies, which can exceed several hundred thousand dollars per treatment.
These estimates vary, but they illustrate how manufacturing complexity contributes to the high cost of many approved therapies.
Producing Therapies Closer to the Patient
One approach being explored is to produce CAR-T therapies closer to where patients are being treated, rather than shipping their cells to centralized manufacturing facilities. Through the nonprofit Caring Cross, Dr. Dropulić and his colleagues have been working on models that support this approach. The concept relies on simplified manufacturing processes and modular cleanroom environments that can be placed near hospitals. This represents a shift away from centralized manufacturing toward more distributed, point-of-care models.
If successful, this model could shorten the timeline between cell collection and infusion. In some cases, CAR-T therapies could be produced and returned to patients in about seven days rather than several weeks.
Decentralized CAR-T models could reduce turnaround time from several weeks to as little as seven days.
For patients waiting for treatment, that difference can be life-defining.
Expanding Access Outside the United States
The challenge becomes even more pronounced outside the United States, where cost, infrastructure, and supply chain limitations further restrict access. Therapies priced in the hundreds of thousands of dollars are difficult for many healthcare systems to support, and cost and infrastructure can limit availability even when the science exists.
Caring Cross has partnered with organizations in countries such as Brazil and India to help establish local manufacturing programs. These collaborations focus on technology transfer, training, and clinical development to enable therapies to be manufactured within the region. These efforts aim to establish self-sustaining regional manufacturing ecosystems rather than relying on imported therapies. The goal is to lower costs while maintaining the quality and regulatory standards required for advanced therapies.
These programs also point to a different model for developing and distributing advanced therapies globally. Rather than relying entirely on centralized manufacturing in a few countries, regional production networks could allow therapies to be adapted to local healthcare systems while maintaining consistent manufacturing standards.
Decentralized manufacturing models could help address access gaps by allowing hospitals to serve as a “safety net” when commercial therapies are unavailable or impractical – particularly for rare cancers or small patient populations that may not attract traditional commercial investment. For example, some rare cancers or small patient populations may not attract commercial development, even when promising targets exist. In these situations, hospitals or research centers could use local manufacturing capabilities to produce therapies for patients who might otherwise have no options.
Alternative Approaches to Gene Delivery
The panel also explored emerging approaches that could further reshape how gene therapies are delivered.
For example, one area being explored is in vivo gene delivery, where genetic instructions are delivered directly into the body instead of modifying cells outside the patient. If these approaches succeed, they could simplify treatment. However, these approaches still face open questions around safety, control, and scalability. For now, however, therapies built from a patient’s own cells remain the most established option.
New tools may also support more distributed production models. Technologies such as supply chain tracking, automation, and machine learning could improve oversight of complex production workflows and help coordinate decentralized manufacturing networks.
While the science behind cell and gene therapy continues to advance rapidly, the discussion made clear that access – not innovation – is now the defining challenge for the field. Expanding manufacturing capacity, reducing costs, and building new delivery models will be critical to ensuring these therapies reach the patients who need them most.
Key Takeaways
- Advances in viral vector technology have enabled the development of today’s CAR-T therapies.
- Manufacturing complexity and cost remain key barriers limiting patient access.
- Centralized production models can delay treatment for patients with aggressive disease.
- Distributed, point-of-care manufacturing could significantly reduce vein-to-vein time.
- Global access will depend on regional manufacturing ecosystems and technology transfer.
- Emerging approaches, including in vivo delivery and digital tools, may further reshape how therapies are produced and delivered.
Stay Updated
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About the Guest
Boro Dropulić, PhD MBA.
Co-founder and Executive Director, Caring Cross. CEO, Vector BioMed
Dr. Dropulić received his PhD from the University of Western Australia and his MBA from Johns Hopkins University (JHU). He has worked in the gene therapy field since the late 1980s. Following a Fogarty Fellowship at the NIH, he joined the faculty at JHU, where he worked on developing lentiviral vectors as delivery systems for gene therapy. After four years in academia, he founded his first company, ViRxSys, and led the team that first demonstrated the safety of lentiviral vectors in humans in collaboration with colleagues at the University of Pennsylvania.
He later founded Lentigen, which developed the lentiviral vector used to produce Kymriah®, the first FDA-approved gene therapy product. Recognizing an opportunity to integrate lentiviral vector technology with closed-system automated cell-processing devices, Dr. Dropulić helped pioneer distributive, place-of-care manufacturing at hospitals—an approach aimed at improving the affordability and accessibility of gene therapy products such as CAR-T cells. He subsequently spearheaded the acquisition of Lentigen by Miltenyi Biotec in 2014 and led the development of a global place-of-care network of clinical centers capable of manufacturing CAR-T cell products and demonstrating their therapeutic benefits in clinical trials.
Seeing a need for improved business models to support broader access to gene therapies, Dr. Dropulić co-founded Caring Cross, a 501(c)(3) nonprofit organization, where he serves as Executive Director. He also serves as CEO of Vector BioMed, a public benefit corporation spun out of Caring Cross to provide affordable GMP lentiviral vector manufacturing services to the gene therapy scientific community.