Introducing CAR-T Therapy in Kazakhstan: Establishing Academic-Scale Lentiviral Vector and CAR-T Cell Production
Keyer V. Kydyrbayeva A. Kulatay T. Zauatbayeva G. Bazhenov D. Ingirbay B. Shakhmanova Z. Zhumabekova M. Ospanova M. Shustov A.V.
August 2025Multidisciplinary Digital Publishing Institute (MDPI)
Biomolecules
2025#15Issue 8
CAR-T cell therapy represents a breakthrough in cancer treatment, yet its implementation in developing countries remains challenging due to technical and infrastructural barriers. This study aimed to establish clinical-scale CAR-T production in Kazakhstan, a country with no prior experience in advanced cell and gene therapies. We implemented a complete CAR-T manufacturing pipeline, including in-house lentiviral vector (LV) production and automated CAR-T cell processing using the CliniMACS Prodigy system. Two anti-CD19 CAR LVs were used, one modeled after FDA-approved Kymriah (4-1BB costimulation) and another replicating Yescarta (CD28 costimulation). The vector produced locally achieved functional titers of 1.5 × 1010 TU/mL after concentration. Twelve clinical-scale CAR-T products were manufactured, exhibiting a memory-skewed T-cell phenotype. Functional assessments revealed that CD28-based CAR-T cells produced significantly higher Th1 cytokines (IFN-γ, TNF-α, IL-2; p < 0.05) than 4-1BB-based cells, though both demonstrated comparable cytotoxicity against CD19+ targets. These findings demonstrate the feasibility of establishing CAR-T production in resource-limited settings using a decentralized manufacturing framework. This work provides a scalable model of CAR-T therapy production in developing regions, suitable for clinical implementation using the hospital exemption framework. Critical gaps in access to advanced immunotherapies, including CAR-T, in the Central Eurasia region are addressed.
academic format , CAR-T therapy , CliniMACS Prodigy , developing economy , hospital exemption , point-of-care
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National Center for Biotechnology, Korgalzhin hwy 13/5, Astana, 010000, Kazakhstan
Scientific-Production Center of Transfusiology, Zhanibek Khandar St., 10, Astana, 010000, Kazakhstan
National Center for Biotechnology
Scientific-Production Center of Transfusiology
10 лет помогаем публиковать статьи Международный издатель
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