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Cost-effective strategies for CAR-T cell therapy manufacturing

Abdo, Luiza, Batista-Silva, Leonardo Ribeiro, Bonamino, Martín Hernán·2025·Molecular Therapy Oncology
DOI 10.1016/j.omton.2025.200980PMC PMC12022644
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Graphical abstract CC BY · PubMed Central
Figure 1 CAR-T cell product manufacturing involves several steps, which increase the complexity and cost of this therapy After a patient is indicated for this therapy, the procedure is generally divided into two main phases: the steps carried out in the hospital (shown in purple) and the steps carried out in the manufacturing unit (shown in blue). In the hospital, the patient undergoes leukapheresis and cryopreservation of the cells (if required). The cells are then transported to the production center, which may be in a different country. At the manufacturing unit, T cells are isolated, activated, modified to express the CAR through viral transduction, expanded for several days, frozen, and subjected to quality control. The cells are then shipped back to the hospital. Finally, the patient undergoes conditioning and receives the CAR-T cells. This procedure can take up to one month, depending on the origin of the cells. Efforts to simplify and optimize this production process are currently underway, with major points for improvement highlighted in red in the figure.
Figure 1 CAR-T cell product manufacturing involves several steps, which increase the complexity and cost of this therapy After a patient is indicated for this therapy, the procedure is generally divided into two main phases: the steps carried out in the hospital (shown in purple) and the steps carried out in the manufacturing unit (shown in blue). In the hospital, the patient undergoes leukapheresis and cryopreservation of the cells (if required). The cells are then transported to the production center, which may be in a different country. At the manufacturing unit, T cells are isolated, activated, modified to express the CAR through viral transduction, expanded for several days, frozen, and subjected to quality control. The cells are then shipped back to the hospital. Finally, the patient undergoes conditioning and receives the CAR-T cells. This procedure can take up to one month, depending on the origin of the cells. Efforts to simplify and optimize this production process are currently underway, with major points for improvement highlighted in red in the figure.CC BY · PubMed Central
Figure 2 Reduced expansion time of CAR-T cells contributes to the optimization of the production protocol for these cells The automation of the CAR-T cell production process using a closed system can help reduce the production time of the cell product and eliminate the need for transportation to specialized centers. This approach essentially involves removing cells from the patient, modifying them using non-viral methods (such as transposons, nanoparticles, or CRISPR), performing quality control, and reinfusing them into the patient. This process can be completed in just one day.
Figure 2 Reduced expansion time of CAR-T cells contributes to the optimization of the production protocol for these cells The automation of the CAR-T cell production process using a closed system can help reduce the production time of the cell product and eliminate the need for transportation to specialized centers. This approach essentially involves removing cells from the patient, modifying them using non-viral methods (such as transposons, nanoparticles, or CRISPR), performing quality control, and reinfusing them into the patient. This process can be completed in just one day.CC BY · PubMed Central
Figure 3 Off-the-shelf CAR-T cells offer an alternative to reduce both the time and cost for patients to receive treatment Currently, most CAR-T cell therapies are autologous, involving the extraction, modification, and reinfusion of a patient’s own cells—a process that can take up to three weeks. An alternative to streamline this process is to utilize universal CAR-T cells derived from allogeneic donors, producing multiple doses to treat several patients in less than a week. This approach is referred to as off-the-shelf CAR-T cell therapy. In addition to reducing time and cost, donor cells may be healthier, as they have not been exposed to the invasive treatments that cancer patients typically undergo, such as chemotherapy and radiotherapy.
Figure 3 Off-the-shelf CAR-T cells offer an alternative to reduce both the time and cost for patients to receive treatment Currently, most CAR-T cell therapies are autologous, involving the extraction, modification, and reinfusion of a patient’s own cells—a process that can take up to three weeks. An alternative to streamline this process is to utilize universal CAR-T cells derived from allogeneic donors, producing multiple doses to treat several patients in less than a week. This approach is referred to as off-the-shelf CAR-T cell therapy. In addition to reducing time and cost, donor cells may be healthier, as they have not been exposed to the invasive treatments that cancer patients typically undergo, such as chemotherapy and radiotherapy.CC BY · PubMed Central

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Metadata

Authors
Abdo, L., Batista-Silva, L. R., & Bonamino, M. H.
Venue
Molecular Therapy Oncology
Publisher
Elsevier BV
Published
2025-06
Volume
33
Issue
2
Pages
200980
ISSN
2950-3299
DOI
10.1016/j.omton.2025.200980
PMC
PMC12022644
Cited by
54
References
8
Language
en
Licence
Funders
  • National Council for Scientific and Technological Development
  • Ministério da Saúde
  • Carlos Chagas Filho Foundation for Research Support of Rio de Janeiro State

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