High manufacturing costs are limiting patient access to CAR T cell therapies, according to new research, which indicates that decentralization, vector-free modification technologies, and AI would help make production cheaper.
Making CAR T therapies is an expensive business. A recent study suggested that producing a single batch can cost anywhere between $170,000 and $220,000, depending on the logistical, processing, and distribution steps involved.
The fundamental problem is that CAR T production is not a good fit for centralized manufacturing, according to Martin Bonamino, PhD, leader of the experimental cancer immunotherapy group at Brazil’s National Cancer Institute (INCA).
“CAR T cell therapy is disruptive and involves new production processes. The current model in the pharmaceutical industry is one of centralized production, which involves many logistics and structural costs. In this sense, local strategies, such as point-of-care (POC) production, can help reduce this complexity,” he tells GEN.
POC production involves making the therapy in the hospital or clinic where it will be used, rather than at a separate site. For CAR T therapies, the potential advantages of the approach are obvious, Bonamino says.
“POC can undoubtedly simplify logistics, deliver cells to the patient at more appropriate times, and serve locations that can function as hubs for large regions.”
Bonamino and colleagues made the case for POC manufacturing in a recent study, arguing that eliminating logistics-related costs would significantly reduce COGs.
However, decentralization is not the only cost reduction opportunity, according to Bonamino, who says efforts to replace the viral vectors used in CAR T production with CRISPR, nanoparticle, and mRNA-based methods show real promise.
“Currently, several groups are developing strategies that do not use viral vectors, which would have a significant impact as vectors are one of the most expensive items in the process,” he says.
Other groups are going further and using nanoparticles filled with genetic material to turn circulating T cells into CAR T cells in the patient, in vivo.
This approach, which is being tested in preclinical models, has potential, Bonamino says, explaining, “This in vivo approach would eliminate the laboratory manipulation of the cells, but the balance of risk, effectiveness, and costs has yet to be evaluated.”
Somewhat inevitably, artificial intelligence also has a potential role in reducing CAR T production costs. The most promising potential applications are in-process development and product design, according to Bonamino.
“AI can help us design better CAR Ts, search for novel response biomarkers, and find more efficient manufacturing processes,” he says.
The post Cutting CAR T Costs via Decentralization, Vector-Alternatives, and Artificial Intelligence appeared first on GEN - Genetic Engineering and Biotechnology News.
Making CAR T therapies is an expensive business. A recent study suggested that producing a single batch can cost anywhere between $170,000 and $220,000, depending on the logistical, processing, and distribution steps involved.
The fundamental problem is that CAR T production is not a good fit for centralized manufacturing, according to Martin Bonamino, PhD, leader of the experimental cancer immunotherapy group at Brazil’s National Cancer Institute (INCA).
“CAR T cell therapy is disruptive and involves new production processes. The current model in the pharmaceutical industry is one of centralized production, which involves many logistics and structural costs. In this sense, local strategies, such as point-of-care (POC) production, can help reduce this complexity,” he tells GEN.
POC production involves making the therapy in the hospital or clinic where it will be used, rather than at a separate site. For CAR T therapies, the potential advantages of the approach are obvious, Bonamino says.
“POC can undoubtedly simplify logistics, deliver cells to the patient at more appropriate times, and serve locations that can function as hubs for large regions.”
Cost reduction
Bonamino and colleagues made the case for POC manufacturing in a recent study, arguing that eliminating logistics-related costs would significantly reduce COGs.
However, decentralization is not the only cost reduction opportunity, according to Bonamino, who says efforts to replace the viral vectors used in CAR T production with CRISPR, nanoparticle, and mRNA-based methods show real promise.
“Currently, several groups are developing strategies that do not use viral vectors, which would have a significant impact as vectors are one of the most expensive items in the process,” he says.
Other groups are going further and using nanoparticles filled with genetic material to turn circulating T cells into CAR T cells in the patient, in vivo.
This approach, which is being tested in preclinical models, has potential, Bonamino says, explaining, “This in vivo approach would eliminate the laboratory manipulation of the cells, but the balance of risk, effectiveness, and costs has yet to be evaluated.”
Somewhat inevitably, artificial intelligence also has a potential role in reducing CAR T production costs. The most promising potential applications are in-process development and product design, according to Bonamino.
“AI can help us design better CAR Ts, search for novel response biomarkers, and find more efficient manufacturing processes,” he says.
The post Cutting CAR T Costs via Decentralization, Vector-Alternatives, and Artificial Intelligence appeared first on GEN - Genetic Engineering and Biotechnology News.